A study on probiotics in infants transitioning from partially hydrolyzed formula to standard formula

ISRCTN	ISRCTN94756980
DOI	https://doi.org/10.1186/ISRCTN94756980
Sponsor	H&H (China) Co., Limited
Funder	H&H (China) Co., Limited

Submission date: 04/07/2026
Registration date: 09/07/2026
Last edited: 06/07/2026

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Ke Chen
Principal investigator, Scientific

No. 1617, Section 1, Rìyuè Avenue, Qingyang District
Chengdu City, Sichuan Province
610000
China

ORCID ID	0000-0001-7455-0900
Phone	+86 13981782973
Email	kechen@uestc.edu.cn

Miss Jiayi Zhong
Public

No. 1617, Section 1, Rìyuè Avenue, Qingyang District
Chengdu City, Sichuan Province
610000
China

Phone	+86 18384216052
Email	zjy18384216052@163.com

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Placebo
Assignment	Parallel
Purpose	Supportive care
Participant information sheet	49837_PIS_v1.0_23May2026.pdf
Scientific title	A real-world minimal intervention randomized controlled trial on the effects and health impacts of probiotics on infants switching from partially hydrolyzed formula to regular formula
Study objectives	To evaluate whether supplementation with Bifidobacterium infantis R0033, Bifidobacterium bifidum R0071 and Bifidobacterium helveticus R0052 improves the success rate of transitioning to standard infant formula among infants fed partially hydrolyzed formula under real-world clinical conditions.
Ethics approval(s)	Approved 04/07/2026, Baoxing Center for Disease Control and Prevention (No.1 Zhongling Avenue, Lingguan Town, Baoxing County, Ya’an City, Sichuan Province, 625700, China; +86 0835-6822027; 263662086@qq.com), ref: Research Ethics Approval No. 2026(02)
Health condition(s) or problem(s) studied	Infants fed partially hydrolyzed formula (pHF) for functional dyspepsia syndrome, mild atopic dermatitis (eczema), or step-down treatment of cow’s milk protein allergy
Intervention	The intervention group receives compound probiotic powder sachets weighing 1.5 g each, containing Bifidobacterium infantis R0033 (1.425 × 10⁸ CFU), Bifidobacterium bifidum R0071 (1.425 × 10⁸ CFU), Bifidobacterium helveticus R0052 (9.6 × 10⁹ CFU), 0.75 g fructooligosaccharides (FOS) and 0.56 g maltodextrin. The dosage is one sachet taken twice daily; the powder can be dissolved in an adequate volume of warm water (≤40°C) or mixed with infant formula or complementary foods for oral administration. The control group is given matching placebo powder sachets that only contain 1.5 g maltodextrin without any test probiotic strains, with identical appearance, odor and packaging to the probiotic product; the placebo is administered at the same twice-daily dosage and via the same administration methods as the intervention product. The treatment course commences on the first day of supplementation with either the probiotic or placebo, continues for one full month after the infant achieves successful formula transition, and shall not exceed a maximum total duration of six months.
Intervention type	Supplement
Primary outcome measure(s)	Success rate of transitioning to standard infant formula within the 180-day intervention period measured using a comprehensive clinical assessment including review of feeding logs, evaluation of gastrointestinal symptoms and mental status, together with regular weight measurement using calibrated infant weighing scales. Assessment will be conducted continuously during the 180-day intervention period. The final judgment of transition success is confirmed at 1 month after full conversion to standard formula, and no later than day 180.
Key secondary outcome measure(s)	Final overall formula transition success rate measured using a review of standardized feeding records at the end of the 180-day intervention period One-time formula transition success rate measured using a review of standardized feeding records at the end of the 180-day intervention period Duration of pHF exposure measured using data extracted from subject feeding diaries continuously recorded throughout the 180-day intervention period at the end of the 180-day intervention period Time to stable feeding on standard formula measured using data extracted from subject feeding diaries at immediately once stable formula transition is achieved Proportion of infants reverting back to pHF measured using statistical calculation based on feeding records at the end of the 180-day intervention period Gastrointestinal symptom frequency, duration and severity measured using an assessment using standardized symptom diary cards at all scheduled follow-up visits during the 180-day intervention Atopic symptom frequency, duration and severity measured using standardized symptom diary cards at all scheduled follow-up visits during the 180-day intervention Respiratory symptom frequency, duration and severity measured using standardized symptom diary cards at all scheduled follow-up visits during the 180-day intervention Growth parameters (weight, length, head circumference) measured using calibrated infant anthropometric instruments at all scheduled follow-up visits within 180 days
Completion date	02/06/2028

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	0 Days
Upper age limit	12 Months
Sex	All
Target sample size at registration	100
Key inclusion criteria	1. Infants aged ≤12 months stably fed partially hydrolyzed formula (pHF) for functional dyspepsia, mild atopic dermatitis (eczema) or step-down cow’s milk protein allergy therapy, with no initiation of transition to standard intact-protein formula 2. Written informed consent signed by legal guardians ≥18 years old, who agree to fully comply with the trial feeding regimen 3. No contraindications to home-based standard formula oral challenge; no history of severe cow’s milk protein allergy or comorbidities endangering formula transition safety 4. pHF use independently decided by guardians before enrolment; infants achieve stable tolerance to pHF without clinical need to switch to extensively hydrolyzed or amino acid formula 5. Guardians shall refrain from self-administering probiotics, antibiotics, prebiotics, synbiotics, postbiotics or other gut flora-modulating agents throughout the trial
Key exclusion criteria	1. Infants with congenital malformations, hereditary/metabolic/infectious diseases, gastrointestinal surgery history or other conditions that may interfere with study outcomes 2. Any intake of probiotic strains contained in the study intervention within 1 month prior to enrolment 3. Infants requiring special feeding, including extensively hydrolyzed formula, amino acid formula, metabolic special formula or tube feeding 4. Current or previous participation in other clinical trials 5. Guardians unable to complete scheduled visits and comply with trial procedures 6. Other conditions deemed ineligible for enrolment by the investigator’s clinical judgment
Date of first enrolment	20/07/2026
Date of final enrolment	20/01/2028

Locations

Countries of recruitment

China

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan	The datasets generated during and/or analysed during the current study will be available upon request from Dr. Kechen, kechen@uestc.edu.cn.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	in Chinese version 1.0	23/05/2026	06/07/2026	No	Yes

Additional files

49837_PIS_v1.0_23May2026.pdf: in Chinese

Editorial Notes

06/07/2026: Study’s existence confirmed by the Scientific Research Ethics Review Committee of the Baoxing Center for Disease Control and Prevention, China.