Cranberry and Gut Health in Crohn's Disease
Trial statusCompleted
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAna Maldonado-Contreras
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Cranberry powder
DrugCranberry whole powder equivalent to 100 g of fresh cranberries, 525 mg total (poly)phenols), and approximately 3.6 g of fiber.
Placebo
Dietary supplementplacebo powder (9 g powder, no (poly)phenols, no fibers
Treatment groups
31 Participants
are divided into 2 treatment groupsGroup A: CranberryExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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, %.
Time frame
15 weeksSecondary outcomes
1
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.
Time frame
15 weeks2
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.
Time frame
15 weeks3
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.
Time frame
15 weeks4
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.
Time frame
15 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ana Maldonado-Contreras
Lead sponsor
University of Massachusetts, Worcester
Sponsor institution
Source ClinicalTrials.gov
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