Study on Fecal Microbiota Transfer for Better Diabetes Control in Adults with Type 2 Diabetes After Bariatric Surgery

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for people with Type 2 Diabetes who have not achieved diabetes remission after undergoing bariatric surgery one to five years ago. The treatment being tested is a fecal microbiota transfer (FMT), which involves transferring healthy bacteria from the stool of a donor to the patient. This is done using a special form of the treatment called a double encapsulated oral transplant of fecal microbiota, which is taken by mouth. The study will also use a placebo for comparison.

The purpose of the study is to see if the fecal microbiota transfer can help improve blood sugar control in these patients. Participants will be monitored over a period of time to observe changes in their blood sugar levels, specifically looking at a measure called HbA1c, which reflects average blood sugar levels over the past two to three months. The study will track these changes from the start of the study to six months later, and then continue to follow up for up to two years.

Throughout the study, participants will have regular check-ups to measure their blood sugar levels and other related health indicators. The study aims to understand how effective the fecal microbiota transfer is in helping patients achieve better control of their diabetes and to identify any factors that might predict a good response to the treatment. The safety of the treatment and its impact on the quality of life will also be evaluated.

1 initial visit and baseline assessment

Upon joining the study, an initial visit is conducted to assess your current health status. This includes measuring your blood sugar levels, specifically your HbA1c, which is an indicator of your average blood sugar over the past three months.

Additional tests may include measuring C-peptide levels and evaluating insulin secretion and resistance. These tests help understand how your body is managing insulin and blood sugar.

2 randomization and treatment assignment

You will be randomly assigned to receive either the fecal microbiota transplant (FMT) or a placebo. Both are administered in the form of a double encapsulated oral suspension.

The purpose of this step is to ensure that the study results are unbiased and scientifically valid.

3 treatment administration

The treatment involves taking the assigned capsules orally. The exact dosage and frequency will be provided by the study team, and it is important to follow these instructions carefully.

The treatment period is designed to last for a specific duration, which will be communicated to you during the study.

4 follow-up visits and monitoring

Regular follow-up visits are scheduled to monitor your health and the effects of the treatment. These visits occur at 6 weeks, 12 weeks, 18 weeks, and 24 weeks after starting the treatment.

During these visits, your HbA1c and other health markers will be measured again to track changes and assess the effectiveness of the treatment.

5 long-term follow-up

Additional follow-up visits are planned at 1 year and 2 years post-randomization to evaluate the long-term effects of the treatment.

These visits will include similar assessments as the earlier follow-ups, focusing on your blood sugar levels, insulin function, and overall health.

6 completion of the study

At the end of the study period, a final assessment will be conducted to gather comprehensive data on your health outcomes.

The study team will provide you with information on the results and any further steps if necessary.

Who Can Join the Study?

Must be an adult between 18 and 65 years old.
Must have had Type 2 Diabetes (T2D) before undergoing Bariatric Surgery (BS), which is a type of weight-loss surgery.
Must have had the Bariatric Surgery (either Roux-en-Y gastric bypass or sleeve) 1 to 5 years ago.
Must have had a Body Mass Index (BMI) of 35 or higher before the surgery. BMI is a measure of body fat based on height and weight.
Must be in Non-Diabetic Remission (NDR) at least 1 year after the surgery. This means having an Hba1c level greater than 6.5% and/or fasting blood sugar greater than 6.9 mmol/l, or taking anti-diabetic drugs for at least 2 months. Hba1c is a blood test that shows average blood sugar levels over the past 3 months.
Preferably, should have uncontrolled diabetes with an Hba1c level greater than 7% and be willing to take a proton pump inhibitor (PPI), which is a type of medication that reduces stomach acid.
Must have attended at least 2 out of 3 routine follow-up visits during the first year after surgery (at 3, 6, and 12 months).
Must sign an informed consent form, which is a document that explains the study and confirms your willingness to participate.
Must be affiliated with a social security regime, which means having health insurance, except for AME (State Medical Aid).

Who Cannot Join the Study?

Patients who have not had bariatric surgery (a type of surgery to help with weight loss) 1 to 5 years ago.
Patients who are currently diagnosed with Type 2 Diabetes.
Patients who are not in non-diabetic remission (a state where blood sugar levels are normal without diabetes medication).
Patients who are part of a vulnerable population (groups that may need special protection, such as children or those unable to give consent).

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hopital Beaujon	Clichy	France
Ftnggabwx Cpzucjvyzrvlxpafp Es Dv Npklozlop	Paris	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	16.01.2024

Trial locations

Investigated drugs:

Fecal Microbiota Transfer (FMT) is a therapy that involves taking healthy bacteria from the stool of a donor and transferring it to the gut of a patient. This is done to help restore the natural balance of bacteria in the patient’s intestines. In this clinical trial, FMT is being studied to see if it can help improve blood sugar levels in patients who have had bariatric surgery, which is a type of weight-loss surgery. The goal is to see if FMT can help these patients maintain better control over their blood sugar levels and potentially achieve remission from diabetes.

Investigated diseases:

Type 2 diabetes mellitus

Type 2 Diabetes Mellitus – Type 2 Diabetes Mellitus is a chronic condition that affects the way the body processes blood sugar (glucose). It is characterized by insulin resistance, where the body’s cells do not respond properly to insulin, and eventually, the pancreas may not produce enough insulin. Over time, high blood sugar levels can lead to various complications affecting the heart, blood vessels, nerves, eyes, and kidneys. The progression of the disease can vary, with some individuals experiencing a gradual increase in blood sugar levels, while others may have more rapid changes. Lifestyle factors such as diet, physical activity, and weight management play a significant role in the progression of the disease. Regular monitoring of blood sugar levels is crucial to managing the condition effectively.

Trial ID:

2024-511870-65-00

Protocol code:

APHP180591

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Fecal Microbiota Transfer for Better Diabetes Control in Adults with Type 2 Diabetes After Bariatric Surgery

What is this study about?

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