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Probiotic Supplementation on Weight Loss

Primary Purpose

Bariatric Surgery Candidate

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Probiotic

microcrystalline cellulose

About this trial

This is an interventional supportive care trial for Bariatric Surgery Candidate focused on measuring Probiotic, Microbiome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Probiotic

Placebo

Arm Description

This arm will be receiving probiotic supplements.

This arm will be receiving placebo containing microcrystalline cellulose.

Outcomes

Primary Outcome Measures

Weight loss

Change in body weight from baseline to 3 months

Visceral fat loss

Change in visceral fat from baseline to 3 months

Secondary Outcome Measures

Full Information

NCT ID

NCT03832439

First Posted

February 4, 2019

Last Updated

February 18, 2022

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT03832439

Brief Title

Probiotic Supplementation on Weight Loss

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

January 17, 2019 (Actual)

Primary Completion Date

April 28, 2021 (Actual)

Study Completion Date

April 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bariatric Surgery Candidate

Keywords

Probiotic, Microbiome

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Probiotic

Arm Type

Active Comparator

Arm Description

This arm will be receiving probiotic supplements.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

This arm will be receiving placebo containing microcrystalline cellulose.

Intervention Type

Dietary Supplement

Intervention Name(s)

Probiotic

Other Intervention Name(s)

Culturelle®

Intervention Description

Lactobacillus rhamnosus GG 10 billion cells and microcrystalline cellulose

Intervention Type

Dietary Supplement

Intervention Name(s)

microcrystalline cellulose

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Weight loss

Description

Change in body weight from baseline to 3 months

Time Frame

3 months

Title

Visceral fat loss

Description

Change in visceral fat from baseline to 3 months

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Meera Shah, M.B., Ch.B

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

Learn more about this trial

Probiotic Supplementation on Weight Loss

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