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Intervention study on probiotic solid beverage (Bifidobacterium lactis XLTG11) to improve functional constipation in infants

To evaluate whether daily administration of bifidobacterium lactis XLTG11 improves functional constipation and its concomitant symptoms in infants and young children

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053695
Enrollment
Unknown
Registered
2021-11-27
Start date
2021-11-24
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Functional constipation

Interventions

Experimental group:take evaluate whether daily administration of bifidobacterium lactis XLTG11
Control group:Oral lignolose solution (0.667g lignolose per 1ml) was given 5ml/ time, once a day, taken orally in the morning, for 14 consecutive days

Sponsors

Chengdu Women and Children's Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 3 Years

Inclusion criteria

Inclusion criteria: 1. Rome IV diagnostic criteria at least two of the following symptoms persist for at least 1 month and the following symptoms cannot be explained by another disease: two or less bowel movements per week; history of stool retention; painful or hard bowel movements History of stool; history of bowel movements; large fecal mass in the rectum. At the same time, organic diseases can be excluded before the diagnosis of functional constipation in infants and young children; 2. Term infants, that is, gestational age from 37 to 42 weeks; 3. Birth weight between 2500–4000g; 4. Enrollment age: 6 months to 3 years old; 5. Parents voluntarily defer major changes in infant feeding practices; 6. Parents are willing and able to fill in diaries and questionnaires; 7. Written signed parental informed consent; 8. Periodic and effective visits can be made during the trial period.

Exclusion criteria

Exclusion criteria: 1. Chronic diseases or major medical problems; 2. Gastrointestinal organic diseases; 3. Growth retardation; 4. The mother or child of the breastfeeding child used antibiotics within 2 weeks before randomization and during the trial; 5. Infants (in formula and/or supplements) or their mothers used probiotics within 2 weeks before randomization and during the trial; 6. Has participated in other clinical trials; 7. Food allergies cause constipation (such as milk, eggs and other foods).

Design outcomes

Primary

MeasureTime frame
Defecate frequency;Fecal character;Difficulty in defecating;

Countries

China

Contacts

Public ContactChen Ke

Chengdu Women and Children's Central Hospital

263662086@qq.com+86 13981782973

Outcome results

None listed

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