Prediction of Dietary Intervention Efficacy in Mild Ulcerative Colitis Patients Based on Fecal Microbiome Signatures

NCT05579483 | Unknown

• 1 other identifier: NL79442.091.22
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

A double-blind randomized placebo-controlled parallel trial with two intervention arms and two placebo arms and a period of eight intervention weeks to validate the prediction that prebiotics could induce a higher response in mild UC patients with certain fecal microbiome signatures.

Conditions

Ulcerative Colitis

Keywords

prebiotics; ulcerative colitis; gut microbiome signature; fiber intake; prediction

Outcome Measures

Primary Outcomes (1)

• Response between arms at T = 8 weeks

  Within each arm, response will be determined by the mean Patient Simple Clinical Colitis Activity Index (P-SCAAI) score on a nineteen-point scale (from "0: no symptoms" to "19: severest symptom"). It refers to disease activity during the previous week, with higher scores representing worse disease symptoms.

  Response at the end the intervention (T= 8 weeks)

Secondary Outcomes (10)

• Disease activity over time (T= 0, 4, 8, 12, and 60 weeks)

  Disease activity during and after the intervention (at T= 0, 4, 8, 12, and 60 weeks)

• Mucosal inflammation

  Change during and after the intervention (at T= 0, 8, 12, and 60 weeks)

• GI complaints

  Change during the intervention (at T= 0, 4, and 8 weeks)

• Stool consistency

  Change during the intervention (at T= 0, 4, and 8 weeks)

• Stool frequency

  Change during the intervention (at T= 0, 4, and 8 weeks)]

Other Outcomes (2)

• Habitual dietary intake

  FFQ will be taken at T= 0 (baseline).

• Participants demographics and characteristics

  This information will be collected at T= 0 (baseline).

Study Arms (4)

Predicted responders with prebiotics

EXPERIMENTAL

Predicted responders, which are defined as UC patients having a relative abundance of Bacteroidetes \<=10% in their feces, will receive 6 grams of prebiotics per day.

Dietary Supplement: Prebiotics

Predicted responders with placebo

PLACEBO COMPARATOR

Predicted responders, which are defined as UC patients having a relative abundance of Bacteroidetes \<=10% in their feces, will receive 6 grams of placebo per day.

Dietary Supplement: Placebo

Predicted non-responders with prebiotics

EXPERIMENTAL

Predicted non-responders, which are defined as UC patients having a relative abundance of Bacteroidetes \>=15% in their feces, will receive 6 grams of prebiotics per day.

Dietary Supplement: Prebiotics

Predicted non-responders with placebo

PLACEBO COMPARATOR

Predicted non-responders, which are defined as UC patients having a relative abundance of Bacteroidetes \>=15% in their feces, will receive 6 grams of placebo per day.

Dietary Supplement: Placebo

Interventions

Prebiotics DIETARY_SUPPLEMENT

The prebiotics consists of three non-digestible carbohydrates (40% acacia gum, 20% partially hydrolyzed guar gum, and 40% resistant starch). During the 8-week intervention, two sachets (3 g per sachet) will be consumed per day, one in the morning and one in the evening.

Predicted non-responders with prebiotics; Predicted responders with prebiotics

Placebo DIETARY_SUPPLEMENT

The placebo consists of two digestible carbohydrates (20% maltodextrin and 80% corn starch). During the 8-week intervention, two sachets (3 g per sachet) will be consumed per day, one in the morning and one in the evening.

Predicted non-responders with placebo; Predicted responders with 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:

• Male and female subjects aged 18 to 65 years
• Body Mass Index (BMI) between 18 and 30 kg/m2 (self-reported)
• Ulcerative Colitis confirmed via previous endoscopy and histology
• Mild active UC as defined by P-SCCAI score of 3 to 5 (range 0 to 19)
• Frequent relapse (at least one exacerbation in the last two years)
• No known allergy to any components of the study product (self-reported)
• Signed informed consent
• Stable UC medication defined as no switch to other medication or no dose change
• Mobile phone on which apps (used for questionnaires) can be downloaded (iOS version 9 and newer, Android version 4.4 and newer. Phones manufactured after 2013 are usually suitable)
• Stable dietary pattern during the study

You may not qualify if:

• Any other underlying disease of the GI-tract or previous bowel surgery, except cholecystectomy and appendectomy
• Pregnancy or intending to become pregnant during the study
• Use of medication that can interfere with the study outcomes, as judged by the medical supervisor
• The need for antibiotic use during the intervention period
• Systemic antibiotics and proton pump inhibitors (except for omeprazole and pantoprazole with dosage \<20 mg), prebiotic supplements, probiotic supplements four weeks prior to study start
• Currently participating in another intervention study
• Acquaintances of anyone in the research team

Sponsors & Collaborators

• Wageningen University: lead
• Winclove Probiotics B.V.: collaborator
• China Scholarship Council: collaborator

Study Sites (1)

Wageningen University

Wageningen, Gelderland, 6708WE, Netherlands

Location

Related Publications (2)

• Liu Z, de Vries B, Gerritsen J, Smidt H, Zoetendal EG. Microbiome-based stratification to guide dietary interventions to improve human health. Nutr Res. 2020 Oct;82:1-10. doi: 10.1016/j.nutres.2020.07.004. Epub 2020 Jul 21.

  PMID: 32889252 BACKGROUND

• Fassarella M, Blaak EE, Penders J, Nauta A, Smidt H, Zoetendal EG. Gut microbiome stability and resilience: elucidating the response to perturbations in order to modulate gut health. Gut. 2021 Mar;70(3):595-605. doi: 10.1136/gutjnl-2020-321747. Epub 2020 Oct 13.

  PMID: 33051190 BACKGROUND

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Prebiotics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages

Study Officials

• Erwin G Zoetendal, PhD

  Laboratory of Microbiology, Wageningen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erwin G Zoetendal, PhD

CONTACT

+31 (0)317- 483111; erwin.zoetendal@wur.nl

Zhuang Liu, MSc

CONTACT

+31 (0)617 659 164; zhuang.liu@wur.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Neither the investigator, the participants, nor the outcome assessor will know who received what. No Care Provider is included in this trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: A randomized, placebo-controlled, parallel, double-blind trial with two intervention arms and two control (placebo) arms.

Study Record Dates

• First Submitted: October 4, 2022
• First Posted: October 13, 2022
• Study Start: December 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2025
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)