FMT in Obesity: RYGB vs. LEAN vs. Autologous FMT

Plain-language summary

This study examines the effect of fecal microbiota transplantation (transferring gut microbiota) in people with severe obesity, comparing different donor sources (people who have had gastric bypass, lean donors, or the person's own sample). It enrolls people over 18 with a body mass index of 40 kg/m2 or higher who have prediabetes or diabetes. The study does not use a phase designation and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Recruiting

Sponsor

Wiebke Kristin Fenske

Intervention

Fecal microbiota transplantation

Start date

1/1/2023

Estimated completion

12/31/2025

Countries

Austria

Related genes

Locations

• Graz, Austria

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

\- Inclusion criteria for patients

* Age \>18 years
* Morbid obesity defined by a BMI ≥ 40 kg/m2
* Prediabetes or diabetes with HbA1C between ≥ 5.7 % OR
* Fasting plasma glucose \> 5.6 mmol/l (\> 100 mg/dl) (no caloric intake for at least 8 hours) OR
* Random plasma glucose \> 11.1 mmol/l (\> 200 mg/dl)
* Informed consent

Inclusion criteria for RYGB-FMT intervention donors

* Sustained total weight loss of ≥30% ≥12 months after RYGB surgery
* HbA1c \< 6.5% without insulin treatment or oral antidiabetic medication
* Age \>18 years
* Informed consent

Inclusion criteria for LEAN-FMT intervention donors

* Normal weight (BMI ≥ 20 to \< 25 \>18 years
* Informed consent

Exclusion Criteria:

Exclusion criteria for patients

• Non-Compliance

* Insulin dependent diabetes mellitus, treated with GLP-1 agonists or poorly controlled on oral antidiabetic medications (HbA1C \> 8%)
* Use of any weight loss medication or participation in a weight loss program
* History of recent body weight change (defined as body weight loss or body weight gain of ≥ 5 kg within the two months preceding study enrolment).
* Use of immunosuppressive medication or immune modulators (glucocorticoids, methotrexate, tacrolimus, cyclosporine, thalidomide, interleukin-10 or -11) within the last three months preceding study enrolment.
* Congenital or acquired immunodeficiencies.
* Anatomical reconstruction of the nutrient passage (i.e. hemicolectomy, resection of small bowel, gastrectomy, sleeve gastrectomy, gastric bypass surgery, biliopancreatic diversion, fundoplication etc) or cholecystectomy.
* Chronic diarrhoea
* History of serious chronic disease including malignancy, rheumatic heart disease, endocarditis, or valvular disease (due to risk of bacteremia)
* Any condition, based on clinical judgment that may make study participation unsafe
* Pregnancy or Breast Feeding

Exclusion criteria for RYGB-FMT intervention donors

* Intake of pre-, pro- or antibiotics within \< 3 months before study entry
* Use of immunosuppressive medication or immune modulators (glucocorticoids, methotrexate, tacrolimus, cyclosporine, thalidomide, interleukin-10 or -11) within the last three months preceding study enrolment.
* Congenital or acquired immunodeficiencies.
* Chronic or acute infectious diseases (specified under 6.2.1)
* Drug abuse
* Anatomical reconstruction of the nutrient passage other than surgical RYGB configuration (i.e. hemicolectomy, resection of small bowel, fundoplication, LSG-to-RYGB transformation etc) or cholecystectomy.
* History of recent body weight change (defined as body weight loss or body weight gain of ≥ 5 kg within the two months preceding study enrolment).
* Chronic diarrhoea or steatorrhea or acute gastrointestinal infection within ≤ 3 months before study entry.
* History of serious chronic disease including malignancy, chronic kidney disease (eGFR \< 60 ml/min), heart failure (NYHA ≥ III).
* Any further condition, based on clinical judgment that may disqualify the candidate as an appropriate donor.

Exclusion Criteria for Lean-FMT Intervention Donors • History of overweight or obesity in the past (BMI \> 25 kg/m2)

• History of recent body weight change (defined as body weight loss or body weight gain of ≥ 5 kg within the two months preceding study enrolment).

• HbA1C \> 6.5% or treatment with insulin or oral anti-diabetic medication.

• Use of any weight loss medication or participation in a weight loss program

• Use of immunosuppressive medication or immune modulators (glucocorticoids, methotrexate, tacrolimus, cyclosporine, thalidomide, interleukin-10 or -11) within the last three months preceding study enrolment.

• Congenital or acquired immunodeficiencies.

• Chronic or acute infectious diseases (specified under 6.2.1)

• Drug abuse

• Anatomical reconstruction of the nutrient passage (i.e. hemicolectomy, resection of small bowel, fundoplication etc) or cholecystectomy.

• Chronic diarrhoea or acute gastrointestinal infection within ≤ 3 months before study entry.

• History of serious chronic disease including malignancy, chronic kidney disease (eGFR \< 60 ml/min), heart failure (NYHA ≥ III).

• Any further condition, based on clinical judgment that may disqualify the candidate as an appropriate donor.