NCT05002153

Brief Summary

This past century witnessed a significant increase in the prevalence of obesity, when since 1980 worldwide obesity has more than doubled. According to the World Health Organization, 39% of adults from the age of 18 years or older are overweight while 13% are obese. Successful maintenance of weight loss as losing at least 10% of the initial body weight and maintaining it for at least one year. However, keeping the low body weight is rarely maintained, as 80% of people who lost 10% of their body weight will return to their initial weight within a year. When weight loss is maintained for 2-5 years the chance of long term success was shown to dramatically increase. Although there is no agreement as to what contributes to the recurrent weight regain phenomenon (also known as 'weight cycling' or 'yo-yo diet'), it is strongly associated with the risk of developing metabolic risk factors and their complications including heart disease and all-cause mortality. Altering the gut microbiota is one method to treat disease states associated with gut bacteria. For instance, fecal microbiota transplant (FMT) or fecal bacteriotherapy, is the process of transferring stool from a healthy donor to another. The goal of FMT is to restore host health by increasing diversity and function of the gut microbiota. The main advantage of FMT over probiotics is its ability to transplant the entire gut microbiota and metabolites from the donor to the recipient. Although numerous individual microbes have been identified as related to obesity, multiple studies suggest that loss of microbial diversity has a stronger impact on the development of metabolic dysfunction, this diversity may be restored by FMT. This study will determine whether microbiome modulation might be a possible future target against recurrent obesity in humans, and whether orally administered FMT from a lean donor, post weight loss might be an effective intervention to prevent weight regain.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable obesity

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 12, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

December 28, 2021

Status Verified

December 1, 2021

Enrollment Period

1.2 years

First QC Date

July 27, 2021

Last Update Submit

December 27, 2021

Conditions

ObesityWeight LossFMT

Outcome Measures

Primary Outcomes (2)

  • Microbiome Profiling

    Collection of stool, urine and oral samples for microbiome composition. 16S RNA analysis.

    1.5 years

  • Reaching Target Weight

    Investigate the effect of FMT administration after reaching target weight (kg) on the recurrent weight regain phenomenon.

    1.5 years

Secondary Outcomes (3)

  • Glycemic Response

    1.5 years

  • Metabolic Rate

    1.5 years

  • Substrate Utilization

    1.5 years

Study Arms (2)

Fecal Microbiota Transplantation (FMT)

EXPERIMENTAL

FMT capsules administration - intervention arm

Other: Fecal microbiota transplantation (FMT)

Placebo

PLACEBO COMPARATOR

Placebo capsules administration

Other: Placebo

Interventions

Fecal microbiota transplantation (FMT)OTHER

FMT is the process of transferring stool from a healthy donor to another.

Fecal Microbiota Transplantation (FMT)
PlaceboOTHER

Placebo capsules consist a combination of agarose in normal saline/glycerol (the same vehicle as in a FMT capsules)

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \<BMI\>35
  • Age: 18-65
  • Capable of working with a smartphone application

You may not qualify if:

  • Consumption of antibiotics/probiotics/oral antifungals 3 months prior to the first day of the experiment.
  • Pregnancy, fertility treatments, breastfeeding women six months prior to enrollment and during the study.
  • Chronic disease (e.g. AIDS, Cushing syndrome, CKD, acromegaly, hyperthyroidism/hypothyroidism etc.)
  • Cancer and recent anticancer treatment
  • Psychiatric disorders
  • Coagulation disorders
  • IBD (inflammatory bowel diseases)
  • Bariatric surgery
  • Eating disorders (Anorexia nervosa. Bulimia nervosa. Binge eating disorder, Night eating syndrome).
  • Alcohol or substance abuse
  • Weight loss attempts one year prior to the first day of the experiment - independent or with a dietitian.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Wing RR, Phelan S. Long-term weight loss maintenance. Am J Clin Nutr. 2005 Jul;82(1 Suppl):222S-225S. doi: 10.1093/ajcn/82.1.222S.

    PMID: 16002825BACKGROUND

  • Mackie GM, Samocha-Bonet D, Tam CS. Does weight cycling promote obesity and metabolic risk factors? Obes Res Clin Pract. 2017 Mar-Apr;11(2):131-139. doi: 10.1016/j.orcp.2016.10.284. Epub 2016 Oct 20.

    PMID: 27773644BACKGROUND

  • Wing RR, Hill JO. Successful weight loss maintenance. Annu Rev Nutr. 2001;21:323-41. doi: 10.1146/annurev.nutr.21.1.323.

    PMID: 11375440BACKGROUND

  • Bangalore S, Fayyad R, Laskey R, DeMicco DA, Messerli FH, Waters DD. Body-Weight Fluctuations and Outcomes in Coronary Disease. N Engl J Med. 2017 Apr 6;376(14):1332-1340. doi: 10.1056/NEJMoa1606148.

    PMID: 28379800BACKGROUND

  • Lee P, Yacyshyn BR, Yacyshyn MB. Gut microbiota and obesity: An opportunity to alter obesity through faecal microbiota transplant (FMT). Diabetes Obes Metab. 2019 Mar;21(3):479-490. doi: 10.1111/dom.13561. Epub 2018 Nov 20.

    PMID: 30328245BACKGROUND

  • Thaiss CA, Itav S, Rothschild D, Meijer MT, Levy M, Moresi C, Dohnalova L, Braverman S, Rozin S, Malitsky S, Dori-Bachash M, Kuperman Y, Biton I, Gertler A, Harmelin A, Shapiro H, Halpern Z, Aharoni A, Segal E, Elinav E. Persistent microbiome alterations modulate the rate of post-dieting weight regain. Nature. 2016 Dec 22;540(7634):544-551. doi: 10.1038/nature20796. Epub 2016 Nov 24.

    PMID: 27906159BACKGROUND

Related Links

MeSH Terms

Conditions

ObesityWeight Loss

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • Ilan Youngster, Dr.

    Asaf Harofe Medical Center, Be'er Yaacov, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ilan Youngster, Dr.

CONTACT

+972-506301191youngsteri@asaf.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 27, 2021

First Posted

August 12, 2021

Study Start

January 1, 2022

Primary Completion

March 1, 2023

Study Completion

December 1, 2024

Last Updated

December 28, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share