N/A
Completed N=31
The Role of Lactobacillus Reuteri in Children and Adolescents With Anorexia Nervosa
Source: ClinicalTrials.gov NCT02004288 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcomePrimary: Number of Participants That Drop Out From Rome III Criteria for Constipation — 13; 10 Participants
Summary
The aim of this study is to investigate whether Lactobacillus reuteri could have a beneficial role in treatment of children and adolescents with Anorexia nervosa who develop motility disorder due to the malnutrition regarding the normalization of the motility, as well as the possible role of probiotics on nutritional recovery, especially on bone health.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants That Drop Out From Rome III Criteria for Constipation |
13; 10 | — |
| SECONDARY Normalization of Body Weight |
14; 10 | — |
Eligibility Criteria
Inclusion Criteria
- Pediatric patients with Anorexia nervosa and constipation, aged 8-18 years
Exclusion Criteria
- AN and constipation present for less than 3 month prior to hospitalization
- any disease that affects GI or other systems other than AN or functional constipation
- chronic disorder other than AN
- receiving probiotic and/or prebiotic products 14 days prior to enrolment
- receiving antibiotics 14 days prior to enrolment
- constipation prior AN
- receiving laxative as a therapy for constipation or abuse of laxative to lose weight prior to enrolment
- extraintestinal symptoms: fever, rash
- abnormalities in laboratory findings
- abnormalities in clinical findings: organomegaly, perianal disease
Data sourced from ClinicalTrials.gov (NCT02004288). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.