Study of Fecal Microbiota Transplantation in Capsule Form Compared to Placebo for Patients with Severe Irritable Bowel Syndrome

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What is this study about?

This clinical trial focuses on treating severe Irritable Bowel Syndrome (IBS), a condition that affects the digestive system causing symptoms like abdominal pain, bloating, and changes in bowel habits. The study tests a treatment called Fecal Microbiota Transplantation (FMT), which involves transferring beneficial gut bacteria from healthy donors to patients. The treatment is given in the form of oral capsules containing frozen fecal microbiota.

The purpose of this research is to determine if these oral capsules containing fecal microbiota are effective in reducing the severity of IBS symptoms compared to placebo. The treatment involves taking oral capsules that contain either the fecal microbiota transplant or placebo. The maximum daily dose is 32 grams, and the treatment period lasts for one day.

The study will monitor patients for 24 weeks to assess changes in their IBS symptoms and overall quality of life. The research team will evaluate how the treatment affects the balance of bacteria in the digestive system and track any improvements in IBS-related symptoms. This is a double-blind study, which means neither the patients nor the doctors know who receives the actual treatment or placebo during the study period.

1 Initial assessment

Your participation begins with an evaluation of Irritable Bowel Syndrome (IBS) severity using a special scoring system called IBS-SSS.

The medical team will confirm that your IBS severity score is above 300 points, which indicates severe symptoms.

2 Treatment assignment

You will be randomly assigned to receive either:

– Fecal microbiota transplant capsules: containing processed gut bacteria from healthy donors

– Placebo capsules: identical-looking capsules without active ingredients

Neither you nor your doctor will know which type of capsules you receive.

3 Capsule administration

You will take the assigned capsules by mouth.

The capsules are double-encapsulated, meaning they have two protective layers.

The medical team will provide specific instructions about when and how to take the capsules.

4 12-week assessment

After 12 weeks, you will undergo an evaluation to measure changes in your IBS symptoms.

A stool sample will be collected to analyze the composition of gut bacteria.

You will complete questionnaires about your symptoms and quality of life.

5 24-week follow-up

A final assessment will occur at 24 weeks after taking the capsules.

This includes another evaluation of your IBS symptoms and collection of a stool sample.

You will complete final questionnaires about your symptoms and quality of life.

6 Safety monitoring

Throughout the study period, any health changes or unusual symptoms should be reported.

Regular safety assessments will be conducted to monitor your health status.

Who Can Join the Study?

Must be between 18 and 75 years old
Must have been diagnosed with Irritable Bowel Syndrome (IBS) according to Rome IV criteria, including any of these types:
– IBS with constipation (IBS-C)
– IBS with diarrhea (IBS-D)
– IBS with mixed bowel habits (IBS-M)
Must have severe symptoms with an IBS Severity Scoring System (IBS-SSS) score greater than 300
Must have tried at least two previous treatments that did not work effectively
Must have valid health insurance (AME not accepted)
Must be able and willing to provide written informed consent
Women who can become pregnant must use effective birth control throughout the entire study duration

Who Cannot Join the Study?

Age below 18 or above 65 years
Current pregnancy or breastfeeding
History of inflammatory bowel disease (IBD) such as Crohn’s disease or ulcerative colitis
Previous abdominal surgery in the last 3 months
Current use of antibiotics or having used them in the past 3 months
Active infections or fever
History of severe allergic reactions
Current participation in other clinical trials
Inability to swallow oral capsules
Severe mental health conditions that could affect participation
History of drug or alcohol abuse in the past 12 months
Severe immune system disorders
Uncontrolled diabetes or thyroid disease
Severe liver or kidney disease
Use of medications that could interfere with the study treatment
Known allergies to any components of the study medication

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Hospital Edouard Herriot	Lyon	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
Hopital Beaujon	Clichy	France
Auwrjqvnaa Plgesuxn Htqgzkla Di Mysqmkfow	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	31.01.2025

Trial locations

Investigated drugs:

Fecal Microbiota Transplantation (FMT) is a medical treatment that involves transferring processed stool from healthy donors to patients. In this trial, it is delivered in the form of oral capsules containing frozen material. This therapy aims to restore healthy gut bacteria in patients with severe irritable bowel syndrome. The treatment works by introducing beneficial microorganisms into the patient’s digestive system, which may help improve gut function and reduce symptoms of IBS.

Investigated diseases:

Irritable bowel syndrome

Irritable Bowel Syndrome (IBS) – A chronic functional disorder affecting the digestive system that causes recurring abdominal pain and changes in bowel movements. The condition involves irregular patterns of bowel movements, where a person may experience diarrhea, constipation, or both alternately. IBS can cause bloating, excessive gas, and abdominal discomfort that may be relieved after bowel movements. The severity of symptoms can vary from mild to severe, with some people experiencing periods of symptom flare-ups and remissions. The condition affects the function of the bowel but does not cause permanent damage to the digestive system.

Trial ID:

2024-516099-13-00

Protocol code:

APHP180583

NCT ID:

NCT06433180

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Fecal Microbiota Transplantation in Capsule Form Compared to Placebo for Patients with Severe Irritable Bowel Syndrome

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?