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NCT Number: NCT06495658

Impact of Prebiotics in Ulcerative Colitis

The cause of inflammatory bowel disease (IBD) is currently unknown, although partly attributed to interactions among genetic risk polymorphisms, environmental factors, gut microbiome, and host immunity. Diet, particularly those with plant-based products, have been shown in prior research to improve gut microbial composition, which has been linked to different IBD-related outcomes. This study is interested in evaluating the impact of prebiotics on gut microbiome composition and gut health in patients with IBD.

Dietary composition will be assessed at baseline and over the course of 16 weeks. Participants will be randomized to either consume an 8-week course of prebiotic supplementation beginning at week 0 or week 8. Stool samples will be collected at weeks 0 and 8. The stool will be analyzed for cross-sectional and longitudinal fecal microbial changes associated with different prebiotic and diet consumption patterns in the context of heterogeneous disease characteristics.

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Key information

Conditions

Crohn Disease Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Ulcerative Colitis

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA

Los Angeles, California, 90095, United States

Location status: Recruiting

Location contact

Berkeley Limketkai, MD, PhD

CONTACT

[email protected]

8554238252

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ages 18 to 85 years old
  • History of biopsy-proven ulcerative colitis (UC)
  • Active symptoms (SCCAI >2)
  • Concomitant use of 5-aminosalicylates, immunomodulators, and corticosteroids will be permitted, although initiation or dose adjustment must not have occurred within 30 days prior to enrollment.
  • Concomitant use of biologic therapy will be permitted, although initiation or dose adjustment must not have occurred within 60 days prior to enrollment.
  • Prior probiotics or other dietary supplements use is permitted but will be asked to be discontinued during the course of the trial

Exclusion criteria

  • Prior colectomy
  • Hospitalization
  • Urgent need for abdominal surgery
  • Unstable major medical condition
  • Active malignancy under treatment
  • Active alcohol or non-cannabinoid substance abuse
  • Pregnancy or lactation
  • Concerns for non-compliance

Treatment and study plan

Prebiotic

Dietary Supplement

Participants will be asked to take a daily dose of prebiotic supplement for 8 weeks.

Primary outcomes

  1. Clinical remission

    Time frame: Week 8

    Clinical remission will be defined as a Simple Colitis Clinical Activity Index (SCCAI) < 4. Range of SCCAI is 0-20 (higher is more severe).

  2. Change in fecal calprotectin

    Time frame: Week 8

    Fecal calprotectin is a stool test that measures intestinal inflammation

  3. Microbial composition

    Time frame: Week 8

    Microbial composition includes a measurement and characterization of the relative quantity of genera and species.

Secondary outcomes

  1. Clinical response

    Time frame: Week 8

    Clinical response will be defined as a reduction of Simple Colitis Clinical Activity Index (SCCAI). Range of SCCAI is 0-20 (higher is more severe).

  2. Clinical remission

    Time frame: Week 16

    Clinical remission will be defined as a Simple Colitis Clinical Activity Index (SCCAI) < 4. Range of SCCAI is 0-20 (higher is more severe).

  3. Clinical response

    Time frame: Week 16

    Clinical response will be defined as a reduction of Simple Colitis Clinical Activity Index (SCCAI). Range of SCCAI is 0-20 (higher is more severe).

  4. Change in fecal calprotectin

    Time frame: Week 16

    Fecal calprotectin is a stool test that measures intestinal inflammation

  5. Microbial composition

    Time frame: Week 16

    Microbial composition includes a measurement and characterization of the relative quantity of genera and species.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study title

The Clinical and Microbial Impact of Prebiotics in Ulcerative Colitis

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jul 11, 2024
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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