MITI-001 for Irritable Bowel Syndrome

(CURE-IBS-D Trial)

Not yet recruiting at 1 trial location

Overseen By Clinical Research Coordinator

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Stanford University

Must not be taking: Antibiotics, Immunosuppressants, Anticoagulants, Probiotics

Disqualifiers: Inflammatory bowel disease, GI surgery, Immunodeficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 9 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called MITI-001 for individuals with diarrhea-predominant irritable bowel syndrome (IBS-D). The goal is to determine if MITI-001, a mix of healthy gut bacteria, can improve IBS-D symptoms by addressing gut microbiome imbalances common in these patients. Participants should have IBS-D and show signs of gut microbiome imbalance, such as specific breath test results. This trial is not suitable for those with other serious gut issues or recent antibiotic use. As an Early Phase 1 trial, participants will be among the first to receive MITI-001, aiding researchers in understanding how this new treatment works in people.

Is there any evidence suggesting that MITI-001 is likely to be safe for humans?

Research shows that treatments focusing on the gut microbiome may help with irritable bowel syndrome with diarrhea (IBS-D). MITI-001, a mix of 157 types of live bacteria, currently lacks extensive safety data in humans. As this trial is in the early stages, the researchers are primarily assessing the treatment's safety and tolerability. Thus, safety information is still being collected.

Similar treatments, such as using healthy people's stool, have shown promise and are generally safe. This suggests that MITI-001 might also be safe, but it is too early to be certain. While early studies are encouraging, more trials will provide a clearer picture of MITI-001's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for Irritable Bowel Syndrome (IBS), which often include dietary changes, fiber supplements, and medications like antispasmodics or laxatives, MITI-001 offers a new approach. Researchers are intrigued by MITI-001 because it potentially targets the underlying causes of IBS rather than just alleviating symptoms. While conventional treatments primarily focus on symptom management, MITI-001 may work by modulating specific pathways in the gut, offering a more targeted and possibly more effective treatment option for IBS sufferers.

What evidence suggests that MITI-001 might be an effective treatment for IBS-D?

Research shows that treatments targeting gut bacteria can help with diarrhea-predominant irritable bowel syndrome (IBS-D). Studies using antibiotics or special diets focused on gut bacteria have shown improvements in IBS symptoms. Fecal microbiota transplantation (FMT), which alters the balance of gut bacteria, has also shown promise in reducing IBS-D symptoms. In this trial, participants will receive MITI-001, a mix of 157 different bacteria from healthy donor stool, designed to correct the imbalance of gut bacteria in IBS-D patients. The goal is to restore the gut's natural balance, potentially easing IBS-D symptoms. Although MITI-001 has not been tested in humans yet, the concept is based on strong evidence that altering gut bacteria can help with IBS-D. ^{1 4 6 7 8}

Who Is on the Research Team?

Michael Fischbach, PhD

Principal Investigator

Stanford University

Sean P Spencer, MD, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for individuals with irritable bowel syndrome characterized by diarrhea (IBS-D), including those who have experienced travelers' diarrhea. Participants should be diagnosed with IBS and have symptoms that may be related to gut microbiome issues.

Inclusion Criteria

At least 1 of the following measures of microbiome dysfunction: Primary bile acid proportion ≥ 12% in stool samples, or Positive hydrogen breath test (with either glucose or lactulose substrate) (Rezaie 2017)

Normal C-reactive protein level

Willing to use appropriate contraception during the treatment period and for one week after the last study visit

Exclusion Criteria

Simultaneous participation in another interventional clinical trial

Abnormal blood counts

Pregnant, breastfeeding, or planning pregnancy during the study period

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observation

Participants undergo a four-week observation period to quantify baseline symptoms

4 weeks

Treatment

Participants receive pre-treatment with antibiotics followed by administration of MITI-001

9 days

1 visit (in-person) for endoscopic administration, self-administration on subsequent days

Follow-up

Participants are monitored for safety and effectiveness, with visits to collect stool samples and monitor symptoms

3 months

1 visit (in-person) on Day 30, 2 visits (virtual) on Days 60 and 90

What Are the Treatments Tested in This Trial?

Interventions

• MITI-001

Trial Overview The study tests MITI-001, a complex mixture of live bacteria from healthy donors, intended to restore the balance of gut microbiota in patients with IBS-D. The goal is to see if this treatment can reduce or alleviate symptoms associated with IBS-D.

How Is the Trial Designed?

Group I: Intervention arm (MITI-001) Experimental Treatment 1 Intervention

Dosed with MITI-001

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07238790

Use of A Complex Gut Bacterial Consortium (MITI 001) for ... MITI-001 has not yet been tested in humans. However, several RCTs support the role of the gut microbiome in IBS-D pathogenesis. These include ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3468694/

The Irritable Bowel Syndrome Outcome Study (IBSOS) After treatment, 62% of participants receiving MC-CBT described IBS symptoms as much or very much improved compared to 58% of patients receiving S-CBT and 7% on ...

3. researchgate.net researchgate.net/publication/311917681_Irritable_bowel_syndrome_symptom_severity_improves_equally_with_probiotic_and_placebo

(PDF) Irritable bowel syndrome symptom severity improves ... IBS-SSS improved over 12 wk of treatment in all treatment groups, decreasing by a mean ± SD of 44.0 ± 80.2, 50.8 ± 82.4, and 48.3 ± 72.2 in the ...

4. jstage.jst.go.jp jstage.jst.go.jp/article/internalmedicine/advpub/0/advpub_5984-25/_pdf/-char/en

Ramosetron as a Supportive Agent to Continue Nintedanib ... Ramosetron, a selective 5-HT3 receptor antagonist, has shown efficacy in managing irritable bowel syndrome; however, its effects on nintedanib- ...

5. theromefoundation.org theromefoundation.org/wp-content/uploads/Psychometric-Evaluation-of-Patient-Reported-Outcomes-in-Irritable-Bowel-Syndrome-Randomized-Controlled-Trials-A-Rome-Foundation-Report.pdf

Psychometric Evaluation of Patient-Reported Outcomes in ... Self-administered cog- nitive behavior therapy for moderate to severe irritable bowel syndrome: clinical efficacy, tolerability, feasibility. Clin Gastroen-.

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/pdf/10.1111/jne.13471

THE GUT‐MICROBIOTA‐BRAIN AXIS Overall, this review highlights new points of view considering steroid molecules as potential therapeutic approach for gastrointestinal ...

7. downloads.regulations.gov downloads.regulations.gov/FDA-2023-S-0023-0031/attachment_1.pdf

(b) (4) Page 1 ... Novozymes agrees with the publicly available safety data and conclusions summarized ... on alleviating symptoms of irritable bowel syndrome with diarrhea.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27725146/

Identification of an Intestinal Microbiota Signature ... We found IBS symptom severity to be associated negatively with microbial richness, exhaled CH 4 , presence of methanogens, and enterotypes enriched with ...