The Optimal Route of Fecal Microbiota Transplantation for Irritable Bowel Syndrome

NCT05874830 | Unknown

• 1 other identifier: T109/2021
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

Brief Summary

The object of this study is to find out is there an optimal route for the fecal microbiata transplant (FMT) in patients that suffer from irritable bowel syndrome. The investigators compare outcomes in patients with repeated fecal microbiome samples and make symptomatic questionnaires (i.e. IBS-SSS, GSRS) to find out if there is difference in severity of symptoms compared to FMT given in duodenogastroscopy or in coloscopy.

Conditions

IBS - Irritable Bowel Syndrome; Microbial Substitution

Keywords

IBS; FMT; Fecal microbiota transplant; microbiome

Outcome Measures

Primary Outcomes (1)

• Efficacy of the different routes of FMT, for alteration of gut microbiota towards that of the donor.

  The changes in the engraftment of specific bacteria between the active groups is of special interest, and the changes in the microbiota during the whole of study in the intervention group and in the plasebo group.

  Microbiota is tested at prescreening visit, at the baseline and in 4, 12 and 52 weeks after FMT-procedure.

Secondary Outcomes (4)

• The main clinical outcome is reduction of abdominal pain three months after FMT.

  3 months

• GI Symptoms: THE GASTROINTESTINAL SYMPTOM RATING SCALE (GSRS)

  in 3 months and in 1 year points compared to baseline.

• Mood, General Anxiety-Disorder 7 - questionnaire

  The change in the score of questionnaires between the baseline at 3 months and 12 months

• Mood, Beck's Depression Inventory.

  The change in the score of questionnaires between the baseline at 3 months and 12 months

Other Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events as assessed

  through study completion, an average of 1 year

• Broadening of diet

  before intervention and after 3 months.

Study Arms (3)

FMT through colonoscopy

ACTIVE COMPARATOR

Patient gets FMT in ceacum and plasebo in duodenum.

Other: Fecal microbiota transplant or plasebo through endoscopy

FMT through duodenogastroscopy

ACTIVE COMPARATOR

Patient gets plasebo in ceacum and FMT in duodenum.

Other: Fecal microbiota transplant or plasebo through endoscopy

Plasebo

PLACEBO COMPARATOR

Patient gets plasebo in colonoscopy and in gastroscopy.

Other: Fecal microbiota transplant or plasebo through endoscopy

Interventions

Fecal microbiota transplant or plasebo through endoscopy OTHER

Colonoscopy and gastroscopy

FMT through colonoscopy; FMT through duodenogastroscopy; Plasebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult
• years
• known of Finnish language
• IBS, (new or old diagnosis according to Roma III or IV criteria), all subtypes
• Informed consent
• Moderate to severe IBS symptoms, IBS-SSS \> 175

You may not qualify if:

• Pregnancy
• Antibiotic or probiotic treatment, on-going or previous month
• Abuse of drugs, alcohol or medications
• Other diagnosis besides IBS causing the GI symptoms, such as IBD, microscopic colitis or bile acid diarrhea

Sponsors & Collaborators

• Turku University Hospital: lead

Study Sites (3)

Central hospital of Päijät-Häme

Lahti, Paijat-Hame Region, 15850, Finland

RECRUITING

Turku university hospital

Turku, Southwest Finland, 20520, Finland

RECRUITING

Helsinki University Hospital

Helsinki, Uusimaa, 00029, Finland

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Central Study Contacts

Teemu T Puodinketo, MD

CONTACT

+35823139427; teemu.puodinketo@tyks.fi

Kimmo Salminen, MD

CONTACT

+35823130691; kimmo.salminen@tyks.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The patient and the endoscopists are blinded when the FMT/plasebo is given
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Specialist in Gastroenterology and Geriatrics

Model Details: Double blinded plasebo controlled study with two treatment cohorts and one plasebo cohort

Study Record Dates

• First Submitted: April 17, 2022
• First Posted: May 25, 2023
• Study Start: October 15, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: May 25, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FI (3)