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Gut bacteria secrets after Weight-Loss surgery revealed in new study

NCT ID NCT07381140

What the study statuses mean

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Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This observational study tracks 100 adults to see how Roux-en-Y gastric bypass surgery changes gut bacteria and related metabolic products over 12 months. Participants include people having surgery, those with obesity on diet alone, and healthy normal-weight individuals. Researchers will compare stool and blood samples to understand links between gut changes, weight loss, and health improvements.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help identify gut bacteria patterns that predict better weight loss and metabolic health after gastric bypass surgery.
What could go wrong
This is an observational study, not a treatment trial. It will not test any new therapy, and results may not lead to direct clinical changes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Obese subjects attending the clinical nutrition outpatient clinic of the IRCCS "Saverio de Bellis" - Castellana Grotte (BA).

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria (RYGB Group): * Age between 18 and 65 years. * Adults with a body mass index (BMI) ≥ 35 kg/m² with related comorbidities, or BMI ≥ 40 kg/m², who are candidates for Roux-en-Y gastric bypass (RYGB) surgery only. Exclusion Criteria (RYGB Group): * Treatment with antibiotics within the last 3 weeks, or probiotics/prebiotics within the last 4-6 weeks, or systemic corticosteroids within the 8 weeks prior to baseline (T0). * Participation in dietary regimens or calorie restriction programs in the weeks prior to enrollment. * Chronic inflammatory bowel diseases (e.g., Crohn's disease, ulcerative colitis), ongoing enteric infections, or active neoplasms. * Previous organ transplant or ongoing systemic immunosuppressive therapy. * Pregnancy or breastfeeding. * Previous major gastrointestinal surgery. * Chronic alcohol consumption above moderate levels or substance use disorder. Inclusion Criteria (Obese Control Group): * Age between 18 and 65 years. * Adults with BMI ≥ 30 kg/m² who are candidates for structured dietary treatment. Inclusion Criteria (Healthy Control Group): * Age between 18 and 65 years. * Normal weight (BMI between 18.5 and 24.9 kg/m²). * Normal metabolic function: fasting glucose below threshold, normal ALT/AST, no diagnosis of diabetes or metabolic syndrome. * No chronic gastrointestinal diseases or conditions that could alter the gut microbiota. Exclusion Criteria (Obese Control and Healthy Control Group): * Use of antibiotics within the last 3 weeks or probiotics/prebiotics within the last 4-6 weeks. * Recent gastrointestinal surgery. * Pregnancy or breastfeeding. * Extreme diets or recent dietary changes. * Recent international travel that could have affected the gut microbiota. * Medications known to influence the gut microbiota (e.g., PPIs, metformin, steroids). * Active smoking or excessive alcohol consumption. * Significant gastrointestinal symptoms (chronic diarrhea or constipation).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

    Castellana Grotte, BA, 70013, Italy

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