Cranberry and Gut Health in Crohn's Disease

This study is looking at whether a cranberry powder supplement can improve gut health in adults with Crohn's disease (CD). People with CD often have an imbalance in their gut bacteria, and cranberry compounds might help beneficial bacteria. You would be randomly assigned to take either cranberry powder or a placebo (an inactive powder) once daily for 10 weeks. The main goal is to see if the cranberry powder changes the amount of certain beneficial gut bacteria (butyrate-producing Clostridia species). To join, you need to be an adult with confirmed Crohn's disease, with moderate to severely impaired quality of life, and your CD activity should be lower than sCDAI<450. The current status of this study is unclear, and it plans to enroll 50 people.

Study design
This is a randomized, double-blind, placebo-controlled study involving 50 participants. This means participants are randomly assigned to one of two groups, and neither you nor the researchers will know if you are receiving the cranberry powder or the placebo.
What's involved
You would take a supplement daily for 10 weeks. You will also complete online questionnaires and provide blood, urine, and stool samples at four different times over a total of 15 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 15 weeks, which includes a follow-up period after the 10-week supplement use.

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NCT07170462

Cranberry and Gut Health in Crohn's Disease

Recruiting
EARLY_PHASE1Ages 18–65InterventionalBasic science
Ana Maldonado-Contreras
~50 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:Cranberry powderPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in relative abundance of butyrate-producing Clostridia species, assessed with shotgun metagenomic sequencing and MetaPhlAn taxonomic profiling
Measured over 15 weeks
Crohn Disease (CD)
Crohn Disease
1 sites across 1 states
Massachusetts1
  • Ana Maldonado-Contreras, PhD · PRINCIPAL_INVESTIGATOR · University of Massachusetts, Worcester

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Eligibility criteria

Inclusion

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.

Exclusion

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
  • Change in relative abundance of butyrate-producing Clostridia species, assessed with shotgun metagenomic sequencing and MetaPhlAn taxonomic profiling15 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, %.