Crohn Disease · Crohn Disease (CD)
Cranberry Powder and Gut Health in Adults With Crohn's Disease
Researchers are studying whether 10 weeks of daily cranberry powder, compared with placebo, changes the gut microbiome, inflammation, symptoms, and quality of life in adults with Crohn's disease.
Registry title: Cranberry and Gut Health in Crohn's Disease
1 recruiting U.S. site ↓Study at a glance
- Age
- 18 Years–65 Years
- Treatment
- Cranberry powder or Placebo
- Design
- Randomized · Quadruple
- Central study contact
- Madeline Johns508-856-5279MadelineNunez.Johns@umassmed.edu
- Sponsor
- Ana Maldonado-Contreras
Research question
Does taking cranberry powder daily for 10 weeks, rather than a matched placebo, change gut microbiome composition in adults with Crohn's disease, and what changes occur in inflammation, symptoms, and quality of life?
Participant snapshot
Who the study is looking for
- The study is looking for adults ages 18 through 65 with a confirmed Crohn's disease diagnosis.
- The study is looking for people with a short Crohn's Disease Activity Index below 450 and a short Inflammatory Bowel Disease Questionnaire score below 60.
- The study is looking for people whose listed Crohn's disease medications have been stable for the required screening period.
- The study is looking for Massachusetts residents who can take a daily study powder and complete home sample collections and other study procedures.
Participation overview
What participation may involve
Participants take cranberry or placebo powder daily for 10 weeks and complete questionnaires, daily reporting, and home collection of stool, urine, and capillary blood samples during a study period described as 15 weeks. What participation may involve: - Take one assigned serving of cranberry or placebo powder each day for 10 consecutive weeks. - Complete online questionnaires and dietary evaluations, including the short Crohn's Disease Activity Index and short Inflammatory Bowel Disease Questionnaire. - Collect stool, urine, and capillary blood at home at baseline and weeks 6, 10, and 14 using study kits. - Report adverse events and medication changes daily throughout the study. - Return samples using pre-labeled insulated packaging with cold packs. The registry describes a total participation period of 15 weeks, including 10 weeks of assigned powder and a four-week follow-up phase after supplementation. The record describes four home-collection time points—baseline and weeks 6, 10, and 14—but does not state how many in-person or remote study visits are required.
Study interventions
What participants may receive or do
- Cranberry powder: Participants assigned to this group take one daily serving of whole cranberry powder for 10 weeks. The registry describes each serving as equivalent to 100 grams of fresh cranberries, with 525 milligrams of total polyphenols and approximately 3.6 grams of fiber.
- Placebo: Participants assigned to this group take one daily serving of placebo powder for 10 weeks. The registry describes it as a 9-gram powder without polyphenols or fiber, matched to the cranberry powder in appearance and flavor.
Study design
How the comparison works
This is an early Phase 1 interventional study with two parallel groups. Participants take either cranberry powder or placebo, and researchers compare changes in microbiome composition and other health measures. Participants are randomly assigned in a 1-to-1 ratio to the cranberry or placebo group. The registry describes quadruple masking: participants, care providers, investigators, and outcome assessors are masked to group assignment. The control group receives a placebo powder matched to the cranberry powder in appearance and flavor. The placebo contains no polyphenols or fiber. Because assignment is 1-to-1, each group is intended to receive about half of the participants.
Reported activities
Procedures and tests
- Home stool collection for microbiome sequencing and stool calprotectin measurement.
- Home urine collection for analysis of markers related to cranberry intake.
- Home capillary blood collection using a Tasso device, including measurement of C-reactive protein as an inflammation marker.
- The short Crohn's Disease Activity Index questionnaire to assess reported symptoms and disease activity.
- The short Inflammatory Bowel Disease Questionnaire to assess health-related quality of life.
- Dietary evaluations to assess habitual diet.
- Daily reporting of adverse events and medication changes.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must be adults ages 18 through 65.
- Participants must have a confirmed diagnosis of Crohn's disease.
- The short Crohn's Disease Activity Index must be below 450.
- The short Inflammatory Bowel Disease Questionnaire score must be below 60, which the criterion describes as moderately to severely impaired health-related quality of life.
- Listed medications must be at a stable dose at screening: thiopurines, natalizumab, or methotrexate for 12 weeks; anti-TNF therapy, ustekinumab, or vedolizumab for 8 weeks; 5-ASA for 2 weeks; and steroids for 1 week.
- Women who could become pregnant must use at least one highly effective form of contraception throughout the study.
- Participants must be willing and able to take the cranberry supplement daily, collect specimens, complete other procedures, and finish the study.
- Participants must live in Massachusetts and be able to provide written informed consent.
Possible reasons someone may not be able to join
- People with an ostomy are excluded.
- People with a symptomatic or significant stricture, or an obstruction during the past six months, are excluded.
- Pregnant people are excluded.
- Use of the Specific Carbohydrate Diet or the Inflammatory Bowel Disease Anti-Inflammatory Diet within four weeks before screening is exclusionary.
- Use of probiotics within four weeks before screening is exclusionary.
- Use of antibiotics within four weeks before screening is exclusionary.
- Taking more than 20 milligrams of prednisone or an equivalent corticosteroid dose is exclusionary.
- People with recent Clostridioides difficile colitis are excluded, although the registry does not define how recent.
Important unknowns
What the record does not make clear
- Four home sample-collection time points are reported, but the number, format, and location of study visits are not stated.
- The registry gives stability periods for several Crohn's disease medications but does not clearly state which treatments may continue unchanged during the study.
- Four-week restrictions are reported for antibiotics, probiotics, and certain diets, but the record does not describe whether any other medicines or supplements require a washout.
- The record does not explain what treatment is available if Crohn's disease symptoms worsen during the study.
- The record does not say whether colonoscopy or another endoscopic procedure is required.
- The record does not explain which study-related or routine-care costs are covered or billed to insurance.
- The record does not report whether participants receive compensation.
- The record does not report reimbursement or support for travel.
- The study uses online questionnaires and home sample kits, but the record does not state whether all participation can occur remotely.
- The record does not state whether participants can receive cranberry powder after the study or learn their group assignment.
Before contacting the site
Questions for the study team
- How many study visits are required, and which activities can be completed from home?
- Which current Crohn's disease medicines can continue, and must their doses remain stable throughout all 15 weeks?
- What happens if Crohn's disease symptoms worsen, and which rescue treatments are allowed?
- Are colonoscopy, imaging, or any procedures beyond questionnaires and home sample collection required?
- Which study-related costs are covered, and are compensation or travel reimbursements available?
- What does the study team mean by recent C. difficile colitis?
- Are there restrictions on cranberry products, other foods, diets, probiotics, or supplements during the study?
Before changing care
Questions for your gastroenterologist
- Would keeping my current Crohn's disease treatment stable for this study be medically appropriate given my disease history?
- How stable is my Crohn's disease now, and what symptoms or test results would make participation medically concerning?
- What approved treatment or nutrition alternatives should I consider while evaluating this research study?
- Could cranberry powder or the placebo ingredients interact with my medicines, diet, kidney history, or other health conditions?
- How should you and the research team coordinate medication changes, laboratory results, or a flare during the study?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
This study is investigating whether a cranberry-based dietary supplement, rich in polyphenols and fiber, can enhance gut health in individuals with Crohn's disease. People with Crohn's disease often have an imbalance in their gut microbiome (the community of bacteria in the gut). Previous research suggests that cranberry compounds may help support beneficial gut bacteria. In this study, adults with Crohn's disease will be randomly assigned to one of two groups: one group will receive a cranberry supplement to take once daily for 10 weeks, and the other group will receive a placebo (a supplement with no active ingredients). All participants will be asked to complete online questionnaires and collect samples of their blood, urine, and stool at four time points over a total of 15 weeks. These samples will help researchers understand how the cranberry supplement affects the gut microbiome, inflammation, and overall health. Participation is voluntary, and participants can withdraw from the study at any time. The results of this study may help identify new diet-based approaches to improve gut health in individuals with Crohn's disease.
This randomized, double-blind, placebo-controlled clinical trial evaluates the effect of a cranberry dietary supplement-rich in polyphenols and fermentable fiber-on the gut microbiome, inflammation, and health-related quality of life in adults with Crohn's disease (CD). Crohn's disease is a chronic inflammatory bowel disease associated with significant dysbiosis (disruption of the gut microbial community), and patients often experience impaired quality of life despite medical treatment. There is growing interest in food-based strategies that may favorably impact the gut microbiota in individuals with CD. Polyphenols and fermentable fibers found in whole plant foods-especially in cranberries-have demonstrated prebiotic-like effects in preclinical and small-scale human studies. The primary aim of this study is to determine whether daily consumption of a freeze-dried, 100% cranberry powder supplement for 10 weeks improves the gut microbiome composition. Secondary objectives include assessing changes in inflammation, gastrointestinal symptoms, and quality of life, as well as evaluating the persistence of any microbiome shifts during the follow-up period after supplement cessation. Participants are randomized 1:1 to either the intervention group (cranberry) or a control group (placebo; matched in appearance and flavor) and will consume the assigned supplement daily for 10 consecutive weeks. The total study period for each participant is 15 weeks, which includes a 10-week intervention and a 4-week follow-up phase. Participants will be blinded to group assignment, and supplements will be pre-packaged and labeled to maintain allocation concealment. Throughout the study, participants complete questionnaires and collect biological samples at four time points: baseline (week 0), midpoint (week 6), end of intervention (week 10), and follow-up (week 14). Study assessments include the short Crohn's Disease Activity Index (sCDAI), the short Inflammatory Bowel Disease Questionnaire (sIBDQ), and dietary evaluations. These tools are used to assess changes in disease activity, gastrointestinal symptoms, health-related quality of life, and habitual diet. Participants also report any adverse events or changes in medications daily throughout the study. Biological samples collected include stool, urine, and capillary blood (via the Tasso™ device), obtained at each time point using home collection kits. Stool samples are used for 16S rRNA sequencing and metagenomic analysis to characterize microbiome composition and function. Urine and blood are analyzed for markers f cranberry intake. Sample return is facilitated by pre-labeled, insulated packaging with cold packs. Participants receive training materials, including video instructions and support from the study team as needed.
Study design and administration
- Organization
- University of Massachusetts, Worcester
- Organization class
- Other
- Organization study ID
- STUDY00002053
- Lead sponsor
- Ana Maldonado-Contreras
- Sponsor class
- Other
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Basic Science
- Masking
- Quadruple
- Who is masked
- Participant, Care Provider, Investigator, Outcomes Assessor
- Standard age groups
- Adult, Older Adult
Study arms
Experimental
Cranberry
Participants in the intervention arm will be provided with 7 servings of Cranberry whole powder per week. Participants in the intervention arm are expected to consume 1 serving per day of cranberry whole powder for 10 weeks.
Interventions: Drug: Cranberry powder
Placebo Comparator
Placebo
Participants in the placebo arm will be provided with 7 servings of placebo powder (placebo supplement matched in appearance and flavor) per week. Participants in the placebo arm are expected to consume a serving per day of placebo powder for 10 weeks.
Interventions: Dietary Supplement: Placebo
Interventions
Drug
Cranberry powder
Cranberry whole powder equivalent to 100 g of fresh cranberries, 525 mg total (poly)phenols), and approximately 3.6 g of fiber.
Dietary Supplement
Placebo
placebo powder (9 g powder, no (poly)phenols, no fibers
Eligibility
18 Years–65 Years
All
Not accepted
Inclusion criteria (11)
- Adult CD patients between 18 and 65 years old.Registry-derived · unreviewed
- Women of childbearing potential will be required to use at least one form of "highly effective" contraception throughout the study.Registry-derived · unreviewed
- Confirmed diagnosis of Crohn's disease.Registry-derived · unreviewed
- CD activity lower than sCDAI\<450.Registry-derived · unreviewed
- Moderate to severely impaired Health Related Quality of life (HRQoL). sIBDQ score \<60.Registry-derived · unreviewed
- Stable dose of medications at screening; thiopurines, natalizumab, methotrexate (12 weeks), anti-TNF, ustekinumab (8 weeks), vedolizumab (8 weeks), 5-ASA (2 weeks),Registry-derived · unreviewed
- steroids (1 week).Registry-derived · unreviewed
- Willingness and capacity to significantly consume the cranberry supplement daily.Registry-derived · unreviewed
- Willing and able to comply with specimen collection and other study procedures, and to complete the study.Registry-derived · unreviewed
- Able to provide written informed consent.Registry-derived · unreviewed
- Reside in Massachusetts, USA.Registry-derived · unreviewed
Exclusion criteria (11)
- OstomyRegistry-derived · unreviewed
- Presence of symptomatic or significant stricture or history of obstruction in the past 6 monthsRegistry-derived · unreviewed
- PregnancyRegistry-derived · unreviewed
- Use of Specific Carbohydrate Diet of IBD- AID within 4 weeks of screeningRegistry-derived · unreviewed
- Use of probiotics within 4 weeks of screeningRegistry-derived · unreviewed
- Use of antibiotics within 4 weeks of screeningRegistry-derived · unreviewed
- \> 20mg prednisone or equivalentRegistry-derived · unreviewed
- Recent C. difficile colitisRegistry-derived · unreviewed
- Unable to provide informed consent for themselvesRegistry-derived · unreviewed
- PrisonersRegistry-derived · unreviewed
- ChildrenRegistry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Change in relative abundance of butyrate-producing Clostridia species, assessed with shotgun metagenomic sequencing and MetaPhlAn taxonomic profiling
Time frame: 15 weeks
Stool samples will be collected at Baseline and during the intervention. DNA will be extracted and sequenced using paired-end shotgun metagenomics (2×150 bp). Taxonomic profiling will be performed with MetaPhlAn to quantify species-level relative abundance. The primary endpoint is the within-participant change in the summed relative abundance (%) of butyrate-producing Clostridia (clusters IV \& XIVa). For each participant, species-level abundances will be summed to create a composite (%). The primary analysis will compare mean change from Baseline to time points during the intervention between intervention and placebo groups, with results summarized as mean change and between-group differences with 95% CIs. The unit measure is relative abundance, %.
Secondary outcome
Proportion of participants with ≥70-point reduction in short Crohn's Disease Activity Index (sCDAI) score
Time frame: 15 weeks
The short Crohn's Disease Activity Index (sCDAI) questionnaire will be administered at baseline and during the intervention. Scores are calculated from patient-reported symptoms and range from 0 to 600, with higher values indicating more severe disease activity. The outcome is the proportion of participants achieving at least a 70-point reduction in sCDAI score from baseline. The principal comparison is the between-group difference (cranberry intervention vs placebo) in the percentage of participants reaching this clinical response threshold.
Secondary outcome
Mean change in short Crohn's Disease Activity Index (sCDAI) score
Time frame: 15 weeks
The short Crohn's Disease Activity Index (sCDAI) will be used to assess disease activity at baseline and during the intervention. Scores range from 0 to 600, with higher scores reflecting more active Crohn's disease. The outcome is the within-participant change from baseline in sCDAI score. The primary comparison is the between-group difference (cranberry intervention vs placebo) in mean change from Baseline, reported as mean (SD) change and between-group differences with 95% confidence intervals.
Secondary outcome
Proportion of participants achieving short Crohn's Disease Activity Index (sCDAI) <150 points
Time frame: 15 weeks
The short Crohn's Disease Activity Index (sCDAI) will be assessed at baseline and during intervention. Scores range from 0 to 600, with higher scores indicating greater Crohn's disease activity. The outcome is the proportion of participants with sCDAI \<150 after the intervention, which is a commonly accepted definition of clinical remission. The principal comparison is the between-group difference (cranberry intervention vs placebo) in the percentage of participants meeting this remission threshold.
Secondary outcome
Proportion of participants with ≥50% reduction in short Inflammatory Bowel Disease Questionnaire (SIBDQ) score
Time frame: 15 weeks
The short Inflammatory Bowel Disease Questionnaire (SIBDQ) will be administered at baseline and during the intervention to evaluate health-related quality of life in participants with IBD. Scores range from 10 to 70, with higher scores indicating better quality of life. The outcome is the proportion of participants who demonstrate a ≥50% reduction in their SIBDQ score from baseline. The main comparison is the between-group difference (cranberry intervention vs placebo) in the proportion of participants achieving this reduction.
Secondary outcome
Proportion of participants achieving C-reactive protein (CRP) < 5 mg/L measured by high-sensitivity immunoassay
Time frame: 15 weeks
Blood will be collected at baseline and during the intervention. Serum CRP concentration will be quantified using a validated high-sensitivity immunoassay (ELISA). The outcome is the proportion of participants whose CRP is \< 5 mg/L during intervention. The main comparison is the between-group difference (intervention vs placebo) in the proportion meeting this threshold.
Secondary outcome
Proportion of participants with ≥50% reduction in C-reactive protein (CRP) from baseline measured by high-sensitivity immunoassay
Time frame: 15 weeks
Serum CRP will be measured at baseline and during the intervention using ELISA. The outcome is the proportion of participants who achieve ≥50% reduction in CRP compared to baseline. The primary comparison is the between-group difference (intervention vs placebo) in the percentage of participants meeting this criterion.
Secondary outcome
Proportion of participants with ≥50% reduction in stool calprotectin concentration measured by ELISA
Time frame: 15 weeks
Stool samples will be analyzed for calprotectin concentration using ELISA. The endpoint is the proportion of participants achieving a ≥50% reduction from baseline to Week 15. The between-group difference (intervention vs placebo) in the proportion of responders will be compared.
Recruiting locations in the United States
UMASS medical center
RecruitingWorcester, Massachusetts, 10655, United States
Madeline JohnsMadelineNunez.Johns@umassmed.edu
Central study contacts
Registry dates
- First posted
- Sep 12, 2025
- Primary completion
- Aug 15, 2026
- Overall completion
- Aug 15, 2026
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.