Use of A Complex Gut Bacterial Consortium (MITI 001) for the Treatment of Irritable Bowel Syndrome With Diarrhea

ConditionsIBS (Irritable Bowel Syndrome)Diarrhea

Trial statusNot yet recruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

Age18-65

SponsorStanford University

About this trial

While the pathophysiology of diarrhea-predominant irritable bowel syndrome (IBS-D) is complex and heterogeneous, dysbiosis of the gut microbiome is frequently observed, suggesting that a substantial subset of patients with irritable bowel syndrome (IBS) have symptoms that are initiated and/or perpetuated by a microbiome dysfunction. Successful randomized controlled trials (RCT) for IBS-D (Ford 2018; Black 2022) leveraging microbiome-targeted therapies (antibiotics or low microbiome fermentation diets) suggest the gut microbiome is at least partially involved in IBS symptoms. Furthermore, fecal microbiota transplantation (FMT) for patients with IBS-D has demonstrated promising results (El-Salhy 2020), supporting the possibility that altering the microbiome composition could ameliorate IBS-D symptoms.

MITI-001 is a transplantable gut bacterial community composed of 157 live bacterial strains, encompassing 79 genera of commensal bacteria, that have been isolated from healthy donor stool, purified, and banked. The hypothesis of the proposed research is that MITI-001 can target the pathophysiologic lesion in a subset of IBS-D patients, restore the altered microbial metabolic process, and thus alleviate IBS-D symptoms.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 to 65 years inclusive at the time of signing the informed consent.

Diagnosis of IBS-D according to the Rome IV criteria (Lacy 2017).

Primary bile acid proportion ≥ 12% in stool samples, or

Positive hydrogen breath test (with either glucose or lactulose substrate) (Rezaie 2017)

Disqualifiers

Inflammatory bowel disease

Untreated enteric infections

History of gastrointestinal (GI) surgery: All participants with GI surgeries below the pylorus will be excluded from this study. This includes participants with a history of colectomy, segmental colonic resection, and small bowel resections.

Documented severe gastroparesis

Trial design

Design model

Single group

Treatments tested in this trial

MITI-001 administration
Drug
A complex gut bacterial community (MITI-001) will be given endoscopically and orally

Treatment groups

13 Participants

are divided into 1 treatment group

Group A: Intervention arm (MITI-001)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Determine the safety of MITI-001 in the participant population

Incidence of MITI-001-related adverse events

Time frame

up to 90 days

Secondary outcomes

Assess the ability of MITI-001 to restore microbial metabolic function: secondary bile acid metabolism and hydrogen consumption

* Restoration of metabolic normality (i.e., production of DCA and LCA, consumption of hydrogen) * Engraftment of bai (bile acid-inducible) operon-positive organism(s) measured via metagenomic analysis * Primary bile acid proportion \< 12% in stool

Time frame

Day 30 and Day 90

Adequate relief of IBS-D symptoms

• Composite endpoint consisting of: * 50% or greater reduction in the number of days per week with stools of BSS types 6 or 7 * 30% reduction in the weekly average of the worst daily abdominal pain, for at least 50% of the treatment weeks

Time frame

Day 30

Other outcomes

Determine whether restoration of microbial metabolic function leads to a reduction in IBS symptom burden in participants

IBS symptom burden as measured by: * IBS-SSS * Rome IV Questionnaire * BSS * Abdominal Bloating and Distension Pictogram * Gastrointestinal Symptom Rating Scale * IBS-QOL Survey

Time frame

up to 90 days

Measure the extent of engraftment at the taxonomic and cellular level

Percent of participants showing engraftment of \> 30 strains from MITI-001 measured one week after the last dose of MITI-001

Time frame

one week after last dose of MITI-001

Measure the durability of engraftment and community stability over time

Percent of participants showing engraftment of \> 15 strains from MITI-001 measured 90 days after the last dose of MITI-001

Time frame

90 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: