NCT06419530

Brief Summary

A Randomized controlled double-blind clinical study on the effectiveness and safety of probiotic formula in Autistic children with gastrointestinal symptoms.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
25mo left

Started Jun 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress48%
Jun 2024Jun 2028

First Submitted

Initial submission to the registry

May 13, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 17, 2024

Completed
15 days until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

May 23, 2024

Status Verified

May 1, 2024

Enrollment Period

3 years

First QC Date

May 13, 2024

Last Update Submit

May 21, 2024

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum DisorderGut microbiota

Outcome Measures

Primary Outcomes (1)

  • Changes in Behavioral Rating Scale (ABC) scores of children with autism in 12th week and baseline

    This scale lists 57 items of abnormal performance in sensation, behavior, emotion and language, and makes the judgment of "yes" and "no" in each item. (the informant refers to the parents of the child or those who have lived with the child for more than two weeks.) when scoring, make "yes" and "no" to each item, "yes" is the symbol"√", and "no" is not marked. The total score of "yes" items is 158, and the screening limit is 53-67 points. 53 points were used as the diagnostic threshold of autism, and the diagnosis score was 67 points.

    week 12

Secondary Outcomes (8)

  • Changes in Childhood Autism Rating Scale(CARS) before and after treatment

    week 0,4,8,12,24

  • Changes in Social Responsiveness Scale(SRS) before and after treatment

    week 0,4,8,12

  • Changes in Self-Rating Anxiety Scale(SAS) before and after treatment

    week 0,4,8,12

  • Changes in Autism Diagnostic Observation Schedule(ADOS) before and after treatment

    week 0,4,8,12

  • Changes in Gastrointestinal Symptom Rating Scale(GSRS) before and after treatment

    week 0,4,8,12, 24

  • +3 more secondary outcomes

Study Arms (3)

Placebo group

PLACEBO COMPARATOR

In this arm, 4 placebo capsules would be oral administered by participants everyday for 84 days.

Other: placebo capsule

Fecal microbiota transplantation (FMT) group

ACTIVE COMPARATOR

In this arm, 4 FMT capsules would be oral administered by participants everyday for 84 days.

Other: FMT capsule

Probiotic formula group

EXPERIMENTAL

In this arm, 4 Probiotic formula capsules would be oral administered by participants everyday for 84 days.

Other: Probiotic formula capsule

Interventions

Probiotic formula capsuleOTHER

The subjects take 4 capsules a day for 84 days.

Probiotic formula group
placebo capsuleOTHER

The subjects take 4 capsules a day for 84 days.

Placebo group
FMT capsuleOTHER

The subjects take 4 capsules a day for 84 days.

Fecal microbiota transplantation (FMT) group

Eligibility Criteria

Age3 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children and adolescents aged 3-11 years old
  • Clinical diagnosis of ASD, based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-V)
  • Associated with gastrointestinal symptoms for at least 14 days (diarrhea, constipation, abdominal pain, bloating and/or food allergies/intolerances)
  • With guardians who can fully understand the informed consent and voluntarily sign the written informed consent

You may not qualify if:

  • Antibiotics or probiotics used within 1 mont
  • Serious gastrointestinal problems that require immediate treatment (such as life-threatening intestinal obstruction, intestinal perforation, intestinal bleeding
  • Medications related to mental disorders or depression
  • Relying on tube feeding
  • Swallowing dysfunction that unable to take capsules
  • History of severe allergies
  • Paticipation in other clinical studies within 4 weeks
  • Poor compliance and have difficulty in completing follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology, Daping Hospital, The Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • Yanling Wei, MD

    Daping Hospital,Army medical university

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanling Wei, MD

CONTACT

15310354666lingzi016@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate director / Associate professor

Study Record Dates

First Submitted

May 13, 2024

First Posted

May 17, 2024

Study Start

June 1, 2024

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2028

Last Updated

May 23, 2024

Record last verified: 2024-05

Locations

CN(1)