NCT05058131

Brief Summary

This study examines how a fermentable dietary fibre known to promote butyrate production impacts intestinal barrier function, intestinal microbiota, intestinal inflammation, and gastrointestinal symptoms in patients with microscopic colitis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 27, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

November 3, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

April 21, 2022

Status Verified

April 1, 2022

Enrollment Period

1.2 years

First QC Date

September 9, 2021

Last Update Submit

April 20, 2022

Conditions

Microscopic Colitis

Outcome Measures

Primary Outcomes (1)

  • Colonic permeability in vivo

    Difference in urinary sucralose/erythritol excretion ratio between the study arms

    6 weeks

Secondary Outcomes (10)

  • Small intestinal permeability in vivo

    6 weeks

  • Colonic permeability ex vivo in Ussing chambers

    6 weeks

  • Concentrations of intestinal fatty-acid binding protein

    6 weeks

  • Concentrations of lipopolysaccharide-binding protein

    6 weeks

  • Concentratios of faecal calprotectin

    6 weeks

  • +5 more secondary outcomes

Other Outcomes (7)

  • Faecal output measured by a daily diary

    6 weeks

  • Gastrointestinal symptoms measured by Gastrointestinal Symptom Rating Scale

    6 weeks

  • Quality of life measured by EQ-5D-5L questionnaire

    6 weeks

  • +4 more other outcomes

Study Arms (2)

Dietary fibre

ACTIVE COMPARATOR

Butyrate-promoting dietary fibre

Dietary Supplement: Dietary fibre

Placebo compound

PLACEBO COMPARATOR

Placebo compound

Dietary Supplement: Placebo compound

Interventions

Dietary fibreDIETARY_SUPPLEMENT

Dietary fibre as a powder, 24 g per day for 6 weeks

Dietary fibre
Placebo compoundDIETARY_SUPPLEMENT

Maltodextrin powder, 24 g per day for 6 weeks

Placebo compound

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent
  • Diagnosis of microscopic colitis (collagenous or lymphocytic colitis)
  • Active disease with no medication (e.g. budesonide) or stable budesonide treatment with or without symptoms
  • Age between 18-75

You may not qualify if:

  • Previous diagnosis of other organic gastrointestinal disease that interferes with the outcome parameters used in this study (e.g. ulcerative colitis)
  • Previous abdominal surgery which might influence gastrointestinal function, except appendectomy and cholecystectomy
  • History of or present gastrointestinal malignancy or polyposis
  • Diagnosis of gastrointestinal infection within the last 6 months
  • Current diagnosis of dementia, severe depression, major psychiatric disorder, or other incapacity for adequate cooperation
  • Chronic neurological/neurodegenerative disease (e.g. Parkinson's disease)
  • Autoimmune disease (e.g. rheumatoid arthritis)
  • Chronic pain syndromes (e.g. fibromyalgia)
  • Chronic fatigue syndrome
  • Severe endometriosis
  • Coeliac disease
  • Diagnosis of lactose intolerance within the last 3 months
  • Pregnancy or breast-feeding
  • Regular intake of anti-inflammatory and/or other immunosuppressive medication than budesonide within the last 3 months
  • Intake of proton pump inhibitors (e.g. omeprazol) within the last 4 weeks
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Örebro University

Örebro, Örebro County, 703 62, Sweden

RECRUITING

MeSH Terms

Conditions

Colitis, Microscopic

Interventions

Dietary Fiber

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Dietary CarbohydratesCarbohydratesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Robert J Brummer, MD, PhD

    Örebro University, Sweden

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard A Forsgård, PhD

CONTACT

0790614037richard.forsgard@oru.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 9, 2021

First Posted

September 27, 2021

Study Start

November 3, 2021

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

April 21, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)