Study on the Efficacy of Probiotics in the Treatment of Childhood Obesity and Their Effects on Gut Microbiota

NCT07448220 | Active Not Recruiting Phase 2

• 1 other identifier: 2023-1116-10
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 2

Brief Summary

This interventional study aims to evaluate the efficacy of a probiotics supplementation (Bifidobacterium longum subsp. longum Dipro-O and Bifidobacterium longum subsp. longum Dipro-X; dipro Gracfor PROBIOTICS FAST MELT) in treating childhood obesity and its impact on gut microbiota. The study will enroll 60 overweight or obese children aged 3 to 14 years. Participants will be randomly assigned to either a treatment group receiving lifestyle intervention combined with an oral Bifidobacterium preparations for 8 weeks, or a control group receiving lifestyle intervention alone. The primary outcome is the change in sex-specific BMI-for-age percentiles. Secondary outcomes include changes in height, weight, waist circumference, quality of life satisfaction, and alterations in gut microbiota composition analyzed via 16S rRNA gene sequencing.

Conditions

Overweight , Obesity

Keywords

overweight; obesity; Bifidobacterium; children

Outcome Measures

Primary Outcomes (1)

• Body Mass Index (BMI) percentile in children upon administration of probiotics or placebo as assessed anthropometrically

  Differences in BMI percentile in children upon administration of probiotics or placebo

  8 weeks

Secondary Outcomes (4)

• Height (cm) of children upon administration of probiotics or placebo as assessed anthropometrically

  8 weeks

• Microbiota profiles of fecal samples in children upon administration of probiotics or placebo as assessed via 16s rRNA gene sequencing

  8 weeks

• Weight (kg) of children upon administration of probiotics or placebo as assessed anthropometrically

  8 weeks

• Waist circumference (cm) of children upon administration of probiotics or placebo as assessed anthropometrically

  8 weeks

Study Arms (2)

Probiotic

EXPERIMENTAL

One sachet containing Bifidobacterium longum subsp. longum dipro O + Bifidobacterium longum subsp. longum dipro X, at a dose of 5 × 10\^9 CFU per day.

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

A sachet of maltodextrin per day.

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

A sachet of Bifidobacterium longum subsp. longum dipro O + Bifidobacterium longum subsp. longum dipro X, at a dose of 5 × 10\^9 CFU per day.

Probiotic

Placebo DIETARY_SUPPLEMENT

A sachet of maltodextrin per day.

Placebo

Eligibility Criteria

• Age: 3 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Diagnostic Criteria (Refer to the "Expert Consensus on Diagnosis and Management of Childhood Obesity in China"): For children aged 2-5 years, refer to the "Growth Curve for Chinese Children and Adolescents Aged 0-18 Years" to determine the BMI cutoff points for overweight and obesity in Chinese children aged 2-5 years. For children aged 6-18 years, refer to the "Screening for Overweight and Obesity in School-Age Children and Adolescents" to determine the BMI cutoff points for overweight and obesity by age and gender in children aged 6-18 years.
• Age: 3-14 years.
• Fully informed consent: Parents or guardians have been fully informed of the clinical trial procedures, and both have signed the written informed consent form.

You may not qualify if:

• The child has chronic or severe systemic diseases.
• The child has a family history of obesity-related metabolic or endocrine diseases.
• The child has been diagnosed with psychological disorders or psychiatric diseases.
• The child has used antibiotics or probiotic preparations within 4 weeks prior to enrollment.
• The child was enrolled in other clinical studies 4 weeks prior to enrollment.

Sponsors & Collaborators

• Min-Tze LIONG: lead
• Nanxiang Hospital Shanghai: collaborator

Study Sites (2)

Nanxiang Hospital, Jiading District, Shanghai

Jiadingzhen, Shanghai Municipality, 201800, China

Location

Universiti Sains Malaysia

Pulau Pinang, Pulau Pinang, 11800, Malaysia

Location

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Aihua Zhang, MD.

  Nanxiang Hospital, Jiading District, Shanghai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: March 4, 2026
• Study Start: December 1, 2023
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1); CN (1)