Ingestion Effect of Formula Milk With Triple Bifidobacteria Strains on Fecal Quality and Metabolites in Healthy Children

Summary

The goal of this clinical trial is to compare healthy children between 1 to 3 years old. The main question it aims to answer is

1. Is there an effect towards fecal quality after consuming milk formula supplemented with the triple Bifidobacteria strains (Bifidobacterium longum BB536, Bifidobacterium breve M-16V, and Bifidobacterium longum subsp. infantis M-63)?
2. Is there an effect towards short-chain fatty acid composition after consuming milk formula supplemented with the triple Bifidobacteria strains (Bifidobacterium longum BB536, Bifidobacterium breve M-16V, and Bifidobacterium longum subsp. infantis M-63)?
3. Is there an effect towards clinical profile after consuming milk formula supplemented with the triple Bifidobacteria strains (Bifidobacterium longum BB536, Bifidobacterium breve M-16V, and Bifidobacterium longum subsp. infantis M-63)?

The clinical trial period started off with all the participants consuming a milk formula three times a day, for 14 days as a baseline period. Afterwards, the participants were randomly assigned to one of two groups: probiotic and placebo. Following the baseline period, participants in the probiotic group consumed formulated milk supplemented with the triple Bifidobacteria strains, while the placebo group ingested the same formulated milk without adding triple Bifidobacteria strains for 90 days.

Researchers will compare the probiotic and placebo groups to see if there are any effects towards the fecal quality, short-chain fatty acid level and clinical profile after consuming the milk formula.

Conditions

• Children, Only

Interventions

COMBINATION_PRODUCT

Formula milk with triple Bifidobacterium probiotic strain

Formula milk with triple Bifidobacterium strain containing Bifidobacterium longum BB536 (6.9 x 10\^7 CFU/serving), Bifidobacterium breve M16-V (6.9 x 10\^7 CFU/serving), Bifidobacterium longum subsp. infantis M-63 (6.9 x 10\^7 CFU/serving).

OTHER

Formula milk

Formula milk without any addition of probiotic strain

Sponsors & Collaborators

• PT Kalbe Farma Tbk

  collaborator INDUSTRY

• Morinaga Milk Industry Co., LTD

  collaborator INDUSTRY

• Gadjah Mada University

  lead OTHER

Principal Investigators

• Endang Sutriswati Rahayu, Prof. Dr. Ir · Gadjah Mada University

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

12 Months

Max Age

36 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-05-02

Primary Completion

2023-11-09

Completion

2024-03-31

Countries

• Indonesia

Study Locations