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OpenTrials
Completed

NCT Number: NCT03832439

Probiotic Supplementation on Weight Loss

The investigators are trying to better understand how bariatric surgery leads to weight loss, and the role of bacteria that live in the gut in making this happen.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

The investigators are interested in seeing how a probiotic, which is a dietary supplement containing large amounts of 'good' bacteria, can influence the make-up of the gut bacterial population and what effect it has on weight loss and loss of fat. Before undergoing weight loss surgery (sleeve gastrectomy or roux-en-y gastric bypass), study participants will be asked to provide a stool sample to assess the make-up of their gut bacterial population. They will also undergo a limited CT scan of the abdomen and DEXA (Xray) to help assess the amount of fat present inside the body.

After undergoing weight loss surgery (sleeve gastrectomy or roux-en-y gastric bypass), study participants will be given either a probiotic supplement or dummy pill (placebo) for 3 months, in addition to all usual care that occurs after surgery. The CT scan, DEXA scan and stool sample will be repeated at the end of the 3 month period and analyzed for changes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All subjects who are > 18 and < 65 years of age recruited from the Mayo Clinic bariatric surgery clinic
  • Will also meet one of the National Institute of Health's criteria for bariatric surgery, i.e. body mass index (BMI) > 40 kg/m2 or BMI > 35 kg/m2 with significant weight-related comorbidities.
  • Patients will be eligible if they are not on chronic antibiotic therapy and without active systemic illness.

Exclusion criteria

  • Patients with type 1 or 2 diabetes will be excluded due to the known pre-existing changes in the gut microbiome in this population. All patients will not have had exposure to probiotics, prebiotics or antibiotics in the preceding 4 weeks.
  • Patients with allergy to antibiotics precluding the use of standard peri-operative antibiotics (cefazolin and metronidazole) will be excluded.

Treatment and study plan

Probiotic

Dietary Supplement

Lactobacillus rhamnosus GG 10 billion cells and microcrystalline cellulose

Other names: Culturelle®

microcrystalline cellulose

Dietary Supplement

Placebo

Primary outcomes

  1. Weight loss

    Time frame: 3 months

    Change in body weight from baseline to 3 months

  2. Visceral fat loss

    Time frame: 3 months

    Change in visceral fat from baseline to 3 months

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

The Effect of Probiotic Supplementation on Weight Loss, and Its Association With the Gut Microbiome After Bariatric Surgery.

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 6, 2019
Registry last updated
Feb 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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