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

Gadjah Mada University

Status and phase: Active, not recruiting; Phase 1

Conditions: Children, Only

Treatments: Other: Formula milk; Combination Product: Formula milk with triple Bifidobacterium probiotic strain

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06044376

PUIPTProbiotikUGM_P002

Details and patient eligibility

About

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.

Full description

This clinical trial is a study of 3 strains of Bifidobacterium was conducted in infants aged 1-3 years in Indonesia. The general objective of this study was to determine the benefits of combined supplementation of Bifidobacteria strains (B. longum BB536, B. breve M-16V, and B. longum subsp. infantis M-63) in healthy children aged 1-3 years. The study is conducted for 104 days with a baseline period of 14 days and continued with an intervention period of 90 days. Participants is divided into two groups, which are the intervention group and the placebo group. The study will be conducted using a double-blind randomized, placebo-controlled trial design. A total of 100 participants will be selected based on inclusion and exclusion criteria.

During the screening period (day 0), socialization of the research and signing of informed consent will be carried out for participants who are willing to participate. Participants were asked not to consume fermented milk products, probiotics and prebiotic fortified food/drinks while participating in research activities.

During the baseline period (Day 14), the participants were asked to consume control milk and, represented by their parents, were also asked to fill out research diaries in the form of diet records, records of probiotic products and prebiotic fortified food/drinks consumed, type and frequency of bowel movements, health complaints felt (discomfort, headaches, stomachaches, respiratory tract-related illnesses and fever), medication consumption records, days where the participants refused to eat. Participants were asked to collect research documents and collect stool samples on day 14 +/- 1.

During the intervention period, from day 15 to day 104, participants consumed 36 grams of the test product or placebo dissolved in 180 ml per serving with a consumption frequency of 3 times per day. Product consumption will be recorded in the product consumption logbook and on the subject's diary record form. Once every 2 weeks a health profile measurement (weight, height, arm circumference, head circumference, skinfold thickness) and sleep quality will be measured. Participants were asked to collect research documents and stool samples on day 104 +/- 1 with the same procedure as in the baseline period.

Enrollment: 103 patients

Sex: All

Ages: 12 to 36 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age between 12 - 36 months
• Normal nutritional status (z-score height-for-age or z-score weight-for-height: -2 SD < X < 2 SD)
• Has no dairy allergies
• Does not consume breastmilk anymore during the intervention period
• Willing to participate through the whole research period
• Obtain consent from parents or guardians by signing the informed consent form

Exclusion criteria

• Has a history of lactose intolerance, congenital and chronic diseases including irritable bowel syndrome, etc.
• Receive antibiotic or other probiotic supplementation during the 14 day of baseline period.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

103 participants in 2 patient groups, including a placebo group

Probiotic Group

Active Comparator group

Description:

During the baseline period, all participants consumed milk formula without any addition of probiotics three servings per day for 14 days. One serving of milk formula consists of 36 gram that is diluted in 180 mL lukewarm water. The participants in the probiotic group consumed milk formula added 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). The milk formula is consumed three servings per day for 90 days during the intervention period. One serving of milk formula consists of 36 gram that is diluted in 180 mL lukewarm water.

Treatment:

Combination Product: Formula milk with triple Bifidobacterium probiotic strain

Placebo Group

Placebo Comparator group

Description:

During the research period (both baseline and intervention period), all participants consumed milk formula without any addition of probiotics three servings per day for 104 days. One serving of milk formula consists of 36 gram that is diluted in 180 mL lukewarm water.

Treatment:

Other: Formula milk