ClinicalTrials.gg
RecruitingNCT06681246Updated Aug 11, 2026

The Role of Microbiome in Recurrent Obesity Before and After Antibiotic/Placebo Treatment

An interventional study of Antibiotic treatment and Placebo in Obesity and Weight Loss, sponsored by Weizmann Institute of Science. Recruiting at 1 site in Israel. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-11.

Sponsored by Weizmann Institute of Science · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2024; still recruiting 1 year 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 128 studies in Obesity with a site in Israel — 22 open to participants now, 29 under way, 16 of them phase 3. Obesity · Israel.

Planned enrollment
38th of 98
200 · median 128
Started
2024
with 7 others
No phase
55 of 128
7 open now
Primary completion
2026-12
later than 11 of 28 live
Registered
112th of 128
by date

Among the 128 studies in Obesity with a site in Israel, this one is the 38th largest by planned enrollment of the 98 interventional ones that give a count, is one of 8 that started in 2024, is one of 55 with no phase, reaches primary completion later than 11 of the 28 other live ones, and was the 112th registered.

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

Browse Obesity studies →

Open to participants now

22 of the 128 studies in Obesity with a site in Israel are open now. Recruiting first, the newest first:

16 more — sign in →

All 22 open studies →

A study can be open while its sites in Israel have not opened yet or have stopped. Only those recruiting at a site in Israel →

Who these studies take

Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · healthy volunteers too.

The full table on the hub →

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02

Study summary

This past century witnessed a significant increase in the prevalence of obesity. Successful weight loss maintenance is defined as losing at least 10% of the initial body weight and maintaining it for at least one year. However, keeping a 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. 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. Antibiotics consumption is known to influence host glycemic response through changes induced in microbiome composition and function. Therefore, it may be a possible pathway to jumpstart changes in the gut microbiota.

This study will determine whether microbiome modulation might be a possible future target against recurrent obesity in humans and whether orally administered antibiotic treatment post-weight loss might be an effective intervention to prevent weight regain.

Read the detailed description

This is a placebo-controlled, double blinded interventional study evaluating the effect of antibiotic treatment in the prevention of weight regain after a successful weight loss intervention.

Volunteers will be recruited in the following ways: e-mail, and social media. Volunteers wishing to participate will be asked to complete a questionnaire regarding the aforementioned inclusion and exclusion criteria. Volunteers who qualify for the study will be invited to an introductory meeting at the Weizmann Institute of Science. The details of the experiment and potential risks or discomforts involved in it will be presented, after which the volunteers will sign an informed consent form. Volunteers will start the study and become active participants for a maximal duration of one year.

Samples collected for the study will be used for microbiota profiling (stool and oral), metabolomics (stool, blood) and for bomb calorimeter (stool).

The study will comprise of four parts:

  1. Baseline - one week of profiling and screening.
  2. Nutritional intervention - weight loss intervention which will be based on personalized hypocaloric diet restriction. Meetings will occur twice a month starting from the second week of the study for a three-month period.
  3. Antibiotic treatment - 10 days of either antibiotics- Augmentin (amoxicillin+clauvonate), 875mg, 2 /day, or 10 days of placebo pills, 2/day.
  4. Follow-up meetings - total follow up of 9 months after antibiotic/placebo treatment. Meetings will occur once a month for the first 3 months of the follow up period, and once every 3 months, afterwards.
03

Conditions studied

  • Obesity
  • Weight Loss
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 28 \< \< 40
  • Age - 18-65
  • Capable of working with a smartphone application

Exclusion criteria

Exclusion Criteria:

  • Consumption of antibiotics/probiotics/oral antifungals 2 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, to the discretion of the study team (e.g. AIDS, Cushing syndrome, CKD, acromegaly etc.)
  • Cancer and recent anticancer treatment
  • Psychiatric disorders, to the discretion of the study team.
  • 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 6 months prior to the first day of the experiment - using weight loss medication.
  • Drastic changes in nutritional habits six months prior to the first day of the study - to the discretion of the study team.
  • Allergy to penicillin.
  • Life threatening reaction after consumption of cephalosporins.
  • History of CDI
  • Liver disease
  • History of serious unresolved diarrhea in response to antibiotic treatment to the discretion of the study doctor.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Antibiotic treatment

    intervention arm

    Other: Antibiotic treatment

  • Placebo comparator
    Placebo

    placebo capsules administration

    Other: Placebo

Interventions

  • OtherAntibiotic treatment

    10 days of either antibiotics- Augmentin (amoxicillin+clauvonate), 875mg, 2 /day

  • OtherPlacebo

    consist of a combination of agarose in normal saline/glycerol

06

What researchers measure

Primary outcomes

  1. microbiome composition

    using stool and oral samples

    Time frame: 1 year

  2. weight

    weight (kg)

    Time frame: 1 year

Secondary outcomes

  1. glycemic response

    continues glucose monitor (CGM)

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2024 (actual). Primary completion is estimated for Dec 2026, 24 months after the start.

Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 24 months is close to that.

Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 6, 2024
First posted
Nov 8, 2024
StartActual
Dec 11, 2024
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2027
Last update
Aug 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06681246
Lead sponsor
Weizmann Institute of Science
Responsible party
Sponsor
First posted
Nov 8, 2024
Start date
Dec 11, 2024
Primary completion
Dec 2026 (estimated)
Completion
Dec 2027 (estimated)
Last update
Aug 11, 2026

Study contacts

Eran Elinav, Professor
Contact
Eran.Elinav@weizmann.ac.il
+97289349174
Barbara Raykhel
Contact
barbara.raykhel@weizmann.ac.il
+97289346590
Hila Elinav, Doctor
principal investigator · Hadassah Medical Organization

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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