Cranberry and Gut Health in Crohn's Disease

NCT07170462 | Recruiting Early Phase 1 FDA Drug

• 2 other identifiers: STUDY00002053Gift -The Cranberry Institute
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Crohn Disease (CD); Crohn Disease

Keywords

cranberry; dietary supplement; crohn disease

Outcome Measures

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, %.

  15 weeks

Secondary Outcomes (7)

• Proportion of participants with ≥70-point reduction in short Crohn's Disease Activity Index (sCDAI) score

  15 weeks

• Mean change in short Crohn's Disease Activity Index (sCDAI) score

  15 weeks

• Proportion of participants achieving short Crohn's Disease Activity Index (sCDAI) <150 points

  15 weeks

• Proportion of participants with ≥50% reduction in short Inflammatory Bowel Disease Questionnaire (SIBDQ) score

  15 weeks

• Proportion of participants achieving C-reactive protein (CRP) < 5 mg/L measured by high-sensitivity immunoassay

  15 weeks

Study Arms (2)

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.

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.

Dietary Supplement: Placebo

Interventions

Cranberry powder DRUG

Cranberry whole powder equivalent to 100 g of fresh cranberries, 525 mg total (poly)phenols), and approximately 3.6 g of fiber.

Cranberry

Placebo DIETARY_SUPPLEMENT

placebo powder (9 g powder, no (poly)phenols, no fibers

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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),
• 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.

You may not qualify if:

• 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
• \> 20mg prednisone or equivalent
• Recent C. difficile colitis
• Unable to provide informed consent for themselves
• Prisoners
• Children

Sponsors & Collaborators

• Ana Maldonado-Contreras: lead

Study Sites (1)

UMASS medical center

Worcester, Massachusetts, 10655, United States

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Ana Maldonado-Contreras, PhD

  University of Massachusetts Chan Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Madeline Johns

CONTACT

508-856-5279; MadelineNunez.Johns@umassmed.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: September 12, 2025
• Study Start: October 29, 2025
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)