Crohn Disease (CD)Early Phase 1NCT07170462
Cranberry and Gut Health in Crohn's Disease
A Early Phase 1 study testing Cranberry powder in people with Crohn Disease (CD) and Crohn Disease, run by Ana Maldonado-Contreras at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn Disease (CD), Crohn Disease
- What is being tested?
- Cranberry powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2025to 15 Aug 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult CD patients between 18 and 65 years old.
- Women of childbearing potential will be required to use at least one form of "highly effective" contraception throughout the study.
- Confirmed diagnosis of Crohn's disease.
- CD activity lower than sCDAI<450.
- Moderate to severely impaired Health Related Quality of life (HRQoL). sIBDQ score <60.
- Stable dose of medications at screening; thiopurines, natalizumab, methotrexate (12 weeks), anti-TNF, ustekinumab (8 weeks), vedolizumab (8 weeks), 5-ASA (2 weeks),
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- steroids (1 week).
- Willingness and capacity to significantly consume the cranberry supplement daily.
- Willing and able to comply with specimen collection and other study procedures, and to complete the study.
- Able to provide written informed consent.
- Reside in Massachusetts, USA.
Who cannot join
- Ostomy
- Presence of symptomatic or significant stricture or history of obstruction in the past 6 months
- Pregnancy
- Use of Specific Carbohydrate Diet of IBD- AID within 4 weeks of screening
- Use of probiotics within 4 weeks of screening
- Use of antibiotics within 4 weeks of screening
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- > 20mg prednisone or equivalent
- Recent C. difficile colitis
- Unable to provide informed consent for themselves
- Prisoners
- Children
Trial locations and contacts
1 site in 1 country.
United States1 site
UMASS medical center
Worcester, Massachusetts, 10655
About this study
Official title: Effect of Cranberry in Reducing Dysbiosis in Patients With Crohn's Disease
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).
Read more
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.
Read the detailed description
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.
- Conditions
- Crohn Disease (CD), Crohn Disease
- Being tested
- Cranberry powder, Placebo
- Keywords
- cranberry, dietary supplement, crohn disease
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranberry powderDrug
Cranberry whole powder equivalent to 100 g of fresh cranberries, 525 mg total (poly)phenols), and approximately 3.6 g of fiber.
PlaceboDietary supplement
placebo powder (9 g powder, no (poly)phenols, no fibers
| Study group | Role | What they receive |
|---|---|---|
| Cranberry | Experimental | 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. Receives: Drug: Cranberry powder |
| Placebo | Placebo comparator | 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in relative abundance of butyrate-producing Clostridia species, assessed with shotgun metagenomic sequencing and MetaPhlAn taxonomic profiling
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, %.
Measured: 15 weeks
Secondary outcomes (7)
Proportion of participants with ≥70-point reduction in short Crohn's Disease Activity Index (sCDAI) score
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.
Measured: 15 weeks
Mean change in short Crohn's Disease Activity Index (sCDAI) score
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.
Measured: 15 weeks
Proportion of participants achieving short Crohn's Disease Activity Index (sCDAI) <150 points
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.
Measured: 15 weeks
Proportion of participants with ≥50% reduction in short Inflammatory Bowel Disease Questionnaire (SIBDQ) score
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.
Measured: 15 weeks
Proportion of participants achieving C-reactive protein (CRP) < 5 mg/L measured by high-sensitivity immunoassay
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.
Measured: 15 weeks
Proportion of participants with ≥50% reduction in C-reactive protein (CRP) from baseline measured by high-sensitivity immunoassay
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.
Measured: 15 weeks
Proportion of participants with ≥50% reduction in stool calprotectin concentration measured by ELISA
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.
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start29 Oct 2025
- Primary completion15 Aug 2026
- Study completion15 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn Disease (CD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ana Maldonado-Contreras
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ana Maldonado-Contreras, University of Massachusetts, Worcester
- Investigators
- Ana Maldonado-Contreras, PhD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07170462
- Sponsor's protocol ID
- STUDY00002053
- Other IDs
- Gift -The Cranberry Institute
- Status last verified
- Oct 2026
- First submitted
- 17 Jul 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cranberry in Reducing Dysbiosis in Patients With Crohn's Disease
- ClinicalTrials.gov ID
- NCT07170462
- Acronym / sponsor ID
- STUDY00002053
- Conditions
- Crohn Disease (CD), Crohn Disease
- Keywords
- cranberry, dietary supplement, crohn disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Ana Maldonado-ContrerasUniversity, hospital or other
- Study start
- 29 Oct 2025 (actual)
- Primary completion
- 15 Aug 2026 (actual)
- Study completion
- 15 Aug 2026 (actual)
- First posted
- 12 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cranberry | Experimental | Drug: Cranberry powderParticipants 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. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adult CD patients between 18 and 65 years old.
- Women of childbearing potential will be required to use at least one form of "highly effective" contraception throughout the study.
- Confirmed diagnosis of Crohn's disease.
- CD activity lower than sCDAI<450.
- Moderate to severely impaired Health Related Quality of life (HRQoL). sIBDQ score <60.
Key exclusion criteria (11 listed)
- Ostomy
- Presence of symptomatic or significant stricture or history of obstruction in the past 6 months
- Pregnancy
- Use of Specific Carbohydrate Diet of IBD- AID within 4 weeks of screening
- Use of probiotics within 4 weeks of screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cranberry powderCranberry whole powder equivalent to 100 g of fresh cranberries, 525 mg total (poly)phenols), and approximately 3.6 g of fiber. | Drug | Cranberry |
| Placeboplacebo powder (9 g powder, no (poly)phenols, no fibers | Dietary supplement | Placebo |
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, %.
7 secondary outcomes
Proportion of participants with ≥70-point reduction in short Crohn's Disease Activity Index (sCDAI) score
Time frame: 15 weeks
Mean change in short Crohn's Disease Activity Index (sCDAI) score
Time frame: 15 weeks
Proportion of participants achieving short Crohn's Disease Activity Index (sCDAI) <150 points
Time frame: 15 weeks
Proportion of participants with ≥50% reduction in short Inflammatory Bowel Disease Questionnaire (SIBDQ) score
Time frame: 15 weeks
Proportion of participants achieving C-reactive protein (CRP) < 5 mg/L measured by high-sensitivity immunoassay
Time frame: 15 weeks
Proportion of participants with ≥50% reduction in C-reactive protein (CRP) from baseline measured by high-sensitivity immunoassay
Time frame: 15 weeks
Proportion of participants with ≥50% reduction in stool calprotectin concentration measured by ELISA
Time frame: 15 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Maldonado-Contreras, PhD principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Cranberry powder in people with Crohn Disease (CD) and Crohn Disease, run by Ana Maldonado-Contreras at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in relative abundance of butyrate-producing Clostridia species, assessed with shotgun metagenomic sequencing and MetaPhlAn taxonomic profiling (time frame: 15 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.