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Effects of Bifidobacterium (R0033, R0071) combined intervention on gut microbiota and clinical outcomes in lactose intolerant infants with different LCT genotypes: a randomized controlled trial

Effects of Bifidobacterium (R0033, R0071) combined intervention on gut microbiota and clinical outcomes in lactose intolerant infants with different LCT genotypes: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067481
Enrollment
Unknown
Registered
2023-01-09
Start date
2023-01-09
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lactose intolerance

Interventions

LFP group:Lactase + live bifidobacteria (Bifidobacteria bifidobacteria R0071, Infantium bifidobacteria R0033)
LFC group:Lactase + placebo (inactivated live bifidobacterium)

Sponsors

Chongqing Health Center for Women and Children
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: Infants who visited Chongqing Maternal and Child Health Hospital and Maternal and Child Health Hospital of surrounding counties from November 2022 to November 2023 should be diagnosed with lactose intolerance by senior pediatrician or above.

Exclusion criteria

Exclusion criteria: a. The infant received probiotics or antibiotics from birth to enrollment; b. The infant has been fed supplementary food; c. Children with milk protein allergy or inflammatory bowel disease; d. Children suspected or diagnosed with neonatal necrotizing enterocolitis; e. Treatment with lactose free infant formula. f. The legal guardian refuses sign the informed consent.

Design outcomes

Primary

MeasureTime frame
Duration of diarrhea;

Secondary

MeasureTime frame
Frequency of diarrhea;Galactorrhea frequency;Intestinal exhaust frequency;Frequency of crying;Fecal pH value;The amount of diapers used;Cost of economy;Lactose intake after 1 month;

Countries

China

Contacts

Public ContactSun Hailan

Chongqing Health Center for Women and Children

sunhl_cq@qq.com023-60354483

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026