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Stomach bug treatment may boost metabolic health, study investigates

NCT ID NCT07306988

Disease control Sponsor: Nanjing First Hospital, Nanjing Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether treating Helicobacter pylori (Hp), a common stomach infection, can also help improve metabolic syndrome (high blood sugar, cholesterol, and weight). Researchers will give standard Hp treatment alone or with probiotics or berberine to 120 adults. They will measure changes in gut bacteria and metabolic health to see if adding these supplements boosts benefits.

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.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 120 people

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

Started

Apr 2025

Expected to finish

Jun 2026

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.

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: * For H. pylori-naïve infected patients with newly diagnosed metabolic syndrome (MS): 1. Aged 18-65 years; 2. Confirmed H. pylori-positive status by urea breath test (UBT), with no prior eradication therapy; 3. Newly diagnosed MS according to the Chinese Diabetes Society (CDS, 2004 Chinese criteria) ; 4. Voluntarily join the trial and sign informed consent. * For H. pylori-negative healthy controls with normal metabolism: 1. Aged 18-65 years; 2. Confirmed H. pylori-negative status by UBT; 3. Normal metabolic parameters (e.g., blood glucose, lipid profile, blood pressure) without MS; 4. Voluntarily join the trial and sign informed consent. Exclusion Criteria: 1. Hypersensitivity to study drugs (e.g., penicillin, amoxicillin, vonoprazan); 2. Active peptic ulcer confirmed by endoscopy; 3. Prior history of H. pylori eradication therapy; 4. Use of medications for metabolic regulation (e.g., hypoglycemic agents, lipid-lowering drugs, weight-loss drugs) 5. Recent use of antibiotics or bismuth (within 4 weeks) or H2-receptor antagonists/PPIs (within 2 weeks) before enrollment; 6. Current use of corticosteroids, NSAIDs, or anticoagulants; 7. History of esophageal or gastric surgery; 8. Pregnant or breastfeeding women; 9. Severe comorbidities (e.g., hepatic, cardiovascular, pulmonary, renal diseases, inflammatory bowel disease); 10. Chronic alcohol abuse (\>40 g/day for men, \>20 g/day for women); 11. Malignancies (e.g., gastric mucosa-associated lymphoid tissue \[MALT\] lymphoma).

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Conditions

The condition(s) this trial relates to.

abdominal obesity-metabolic syndrome Helicobacter pylori infectious disease metabolic syndrome X

As listed by the trial registrant

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

Helicobacter pylori infections Metabolic syndrome

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

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Nanjing First Hospital, Nanjing Medical University

    RECRUITING

    Nanjing, Jiangsu, 210006, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.