Prebiotic Fructans Effect on 1-3 Years Constipated Children's Bowel Habits

Constipation Clinical Trial

— CONSTICHILD  

Official title:

Double-blind, Randomized Placebo-controlled Trial Investigating the Effect of Prebiotic Fructans on Bowel Habits of Constipated Young Children One to Three Years of Age

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03941925
• Other study ID #: XH-18-016
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: December 2022

Study information

• Verified date: July 2021
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Wei Cai, Doctor
• Phone: 021-25078674
• Email: caiw1978[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to confirm the effectiveness of chicory-derived prebiotic inulin-type fructans on bowel function in young children.

Description:

The aim of the study is to confirm the effectiveness of chicory-derived prebiotic inulin-type fructans on bowel function in young children. It is a double-blind, randomized, placebo-controlled trial.This study plans to recruit into the group of 100 participants (at least 80 of them completed) in 2018-2020.The two groups for the study are product group (prebiotic fructans) and control group (placebo maltodextrin).Duration of intervention is 6 weeks, including 2 weeks for run-in and 4 weeks for intervention.Efficacy parameters are stool consistency (assessed with Amsterdam infant stool scale),stool frequency, stool amount and stool color (assessed with Amsterdam infant stool scale, treatment success, tolerance and acceptability).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 3 Years

Eligibility

Inclusion Criteria:

1. Diagnosis of functional constipation following ROME4 criteria.

2. Subject is otherwise healthy at the time of pre-examination.

3. Subject is aged 1-3 years at the time of pre-examination.

4. Subject and caretaker are able and willing to follow the study instructions.

5. Subject is suitable for participation in the study according to the investigator/physician/study personnel.

6. Written informed consent is given by parent or legal guardian.

Exclusion Criteria:

1. No legal guardian's command of any local language.

2. Organic causes of defecation disorders incl. Hirschsprung disease, Spina bifida, hypothyroidism etc.

3. Other metabolic or renal abnormalities or mental retardation (Child's mental delay).

4. Food allergies or intolerances.

5. Using drugs (e.g. antibiotics) influencing gastrointestinal function (4 weeks before run-in, 6 weeks before intervention).

6. Use of laxatives and labelled pre- and probiotics in the previous 2 weeks before the beginning of run-in (4 weeks before intervention)

7. Subjects who are currently involved or will be involved in another clinical or food study

Related Conditions & MeSH terms

• Constipation

Intervention

Dietary Supplement:
• Prebiotic fructans
Prebiotic group receiving the prebiotic fructans in two doses during the 4-week intervention period.
• Non-prebiotic maltodextrin
Placebo group receiving the non-prebiotic maltodextrin in two doses during the 4-week intervention period.

Locations

Country	Name	City	State
China	Shanghai Xinhua Hospital, affiliated to Shanghai Jiao Tong University, School of Medicine	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	Beneo GmbH

Country where clinical trial is conducted

China, 

References & Publications (1)

Closa-Monasterolo R, Ferré N, Castillejo-DeVillasante G, Luque V, Gispert-Llaurado M, Zaragoza-Jordana M, Theis S, Escribano J. The use of inulin-type fructans improves stool consistency in constipated children. A randomised clinical trial: pilot study. Int J Food Sci Nutr. 2017 Aug;68(5):587-594. doi: 10.1080/09637486.2016.1263605. Epub 2016 Dec 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stool consistency	Assessed by the parents in a continuous daily bowel diary over the study period using the Amsterdam Infant Stool Scale (AISS) comprised of a 4-point scale (A: watery, B: soft, C: formed, D: hard)	4 weeks
Secondary	Stool frequency	Assessed by daily parental reporting.	4 weeks
Secondary	Stool amount and stool colour	Assessed by the parents in a continuous daily bowel diary over the study period using the Amsterdam Infant Stool Scale (AISS). Stool amount will be assessed on a 4-point scale (1: smear, 2: up to 25%, 3: 25.50%, 4: >50%, relative to diaper surface). Stool colour will be assessed on a 6-point scale (I: yellow, II: orange, III: green, IV: brown, V: meconium, VI: clay-coloured)	4 weeks
Secondary	Treatment success	ROME IV criteria still met at the end of the intervention.	4 weeks
Secondary	Faecal microbiota	Stool samples will be analyzed by appropriate molecular biological methods like 16S rRNA gene sequencing to gain insight into the composition of the gut microbiota. Furthermore, metabolites like SCFA and other organic acids will be measured with appropriate chromatographic methods.	4 weeks
Secondary	Faecal Short Chain Fatty Acids concentration	Change in Short Chain Fatty Acids over a four week period.	4 weeks
Secondary	Faecal pH	Change in faecal pH over a four week period.	4 weeks