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Could a High-Fiber powder help kids with type 1 diabetes?

NCT ID NCT06198725

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether a high-fiber supplement called Trimtab can help preserve beta-cell function in children aged 6 to 12 who were recently diagnosed with type 1 diabetes. For 12 weeks, participants will take the supplement daily, and researchers will measure C-peptide levels (a marker of insulin production) and gut bacteria changes. The goal is to see if a simple dietary change can slow the loss of insulin-making cells.

What this could mean

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

Active substance
Trimtab (a high-fiber grain powder)
What this could lead to
If it works, this could point toward a dietary approach to help preserve insulin production in children with new-onset type 1 diabetes.
What could go wrong
This is an early-stage study with only 110 participants, and the intervention is a dietary supplement, not a drug. It may not show a clear benefit, and results may not apply to all children with type 1 diabetes.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 110 people

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

Started

Jan 2024

Expected to finish

Dec 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

6 to 12 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Diagnosed as type 1 diabetes for the first time according to the diagnostic criteria of the American diabetes Association (ADA) in the past 6 months; * One or more antibodies against GAD65, IAA, IA-2, ICA, and ZNT8 are positive; * The daily total dose of insulin per unit weight was less than 0.5 IU/kg/day three days prior to screening; * Fasting C-peptide (FCP)\>0.1 nmol/L (0.3ng/mL); * Age range from 6 to 12 years old; * Have not participated in any other research projects at present; * The guardian signs the informed consent form, the child agrees to the study, and the child over 8 years old signs the informed consent form. Exclusion Criteria: * Suffering from serious chronic and systemic diseases: tumors, immunodeficiency, heart failure, Cushing's syndrome, kidney diseases (including nephrotic syndrome, nephritis, glomerulonephritis, kidney stones, etc.), liver diseases (including autoimmune hepatitis, metabolic liver disease, non-alcoholic fatty liver disease, primary sclerosing cholangitis, chronic, persistent hepatitis, etc.), gallbladder diseases (including cholecystitis, gallstones, etc.), etc; * Suffering from acute or chronic gastrointestinal diseases such as Crohn's disease, ulcerative colitis, gastroesophageal reflux disease, gastrointestinal ulcers, celiac disease, or having defecation three or more times a day in the past week or more, accompanied by watery stools; * Blood pressure ≥ 95th percentile of the same gender, age, and height reference; * Plasma triglycerides of 9 years and below should be ≥ 1.12mmol/L, and triglycerides of 10 years and above should be ≥ 1.46mmol/L; * Used antibiotics within the past month for 3 days or more; * Currently suffering from infectious diseases; * Have the history of gastrointestinal surgery, surgery to remove appendicitis and hernia; * Evidence of pituitary dysfunction; * Use drugs other than insulin that can affect blood sugar levels; * Chromosomal abnormalities (such as trisomy 21 syndrome, Turner syndrome, etc.); * Have taken probiotics and probiotic products continuously for more than 3 days within the first month before enrollment; * Unable to guarantee sufficient time to participate in this project.

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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

    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

  • Children's Hospital of Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, China

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