Infants fed partially hydrolyzed formula (pHF) for functional dyspepsia syndrome, mild atopic dermatitis (eczema), or step-down treatment of cow’s milk protein allergy Other
Conditions
Interventions
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), B
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
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 wit
Sponsors
H&H (China) Co., Limited
Eligibility
Sex/Gender
All
Age
0 Days to 12 Months
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
China
Contacts
Public ContactJiayi Zhong
Outcome results
None listed