Prebiotic EffecT InfanTs

Healthy Clinical Trial

— PETIT  

Official title:

Double-blind, Randomized Placebo-controlled Trial Investigating the Effect of Prebiotic Inulin-type Fructans on Bowel Habits of Infants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04791956
• Other study ID #: 20018m-jhr
• Status: Recruiting
• Phase: N/A
• Start date: March 17, 2021
• Est. completion date: June 2024

Study information

• Verified date: April 2023
• Source: Beneo-Institute
• Contact: Stephan Theis, PhD
• Phone: +49 6359 803 287
• Email: stephan.theis[@]beneo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study aims to confirm the effectiveness of chicory-derived prebiotic inulin-type fructans on stool consistency in infants.

Description:

The fermentation of prebiotic inulin-type fructans leads to a modulation of the gut microbiota composition, in particular to a growth stimulation of bifidobacteria, and the production of organic acids like lactate and short-chain fatty acids (SCFA). The introduction of solid foods is frequently associated with harder stools which are more difficult to pass and can cause painful defecations. Subsequently, the changes in bowel habits associated with weaning and the introduction of complementary foods could be minimized by the addition of prebiotics to complementary foods and, thus, the transition from milk-feeding to family food could be facilitated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 12 Months

Eligibility

Inclusion Criteria:

• Child is healthy at the time of pre-examination

• Child was born on term or preterm (= 32 weeks of gestation)

• Child is aged 6-12 months at the time of pre-examination (for preterm born children (32-37 weeks of gestation), corrected age will be applied)

• Normal growth (weight and length for age between 10th and 90th percentiles, Fenton and Kim 2013)

• Child receives at least one meal per day as complementary feeding

• Child and legal guardian are able and willing to follow the study instructions

• Child is suitable for participation in the study according to the investigator/physician/study personnel

• Written informed consent is given by parent or legal guardian

Exclusion Criteria:

• No legal guardian's command of any local language

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

• Other metabolic or renal abnormalities or psychomotor retardation (e.g. hypotonia)

• Child has allergy to cow's milk protein or lactose intolerance

• Child has been or is currently breast-fed more than once daily (6 weeks before intervention)

• Child has mostly loose or watery stools in = 50% of defecations

• Use of drugs (e.g. antibiotics) influencing gastrointestinal function (6 weeks before intervention)

• Use of laxatives or pre- or probiotic supplements in the previous 4 weeks before intervention

• Child is currently involved or will be involved in another clinical or food study

Related Conditions & MeSH terms

• Diet, Healthy
• Healthy
• Infant Development

Intervention

Dietary Supplement:
• Prebiotic
Daily intake of Inulin-type fructans from chicory
• Placebo
Daily intake of maltodextrin

Locations

Country	Name	City	State
Spain	Hospital Universitari Sant Joan de Reus - Magatzem	Reus
Spain	Hospital Universitari Joan XXIII de Tarragona - Almacén general	Tarragona

Sponsors (4)

Lead Sponsor	Collaborator
Beneo-Institute	Hospital de Tarragona Joan XXIII, Hospital Universitari Sant Joan de Reus, Institut Investigacio Sanitaria Pere Virgili

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Closa-Monasterolo R, Ferre 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	4 weeks
Secondary	Stool frequency	Assessed by daily parental reporting	4 weeks
Secondary	Stool colour	Assessed by the parents in a continuous daily bowel diary over the study period	4 weeks
Secondary	Stool amount	Assessed by the parents in a continuous daily bowel diary over the study period	4 weeks
Secondary	Sleep	Change in sleep behavior assessed by parental questionnaire (Brief Infant Sleep Questionnaire) at the beginning and end of the trial	4 weeks
Secondary	Stool pH	change in stool pH over a four week period	4 weeks
Secondary	stool short-chain fatty acids	change in amount and relative distribution of short-chain fatty acids in stool over a four week period	4 weeks
Secondary	Tolerance and acceptability	Tolerance and acceptability of the study products assessed by customized parental questionnaire at the end of the trial	4 weeks
Secondary	Body weight	changes in body weight (kg) assessed by an investigator	4 weeks
Secondary	Body height	changes in body height (m) assessed by an investigator	4 weeks
Secondary	Faecal Microbiota	Stool samples will be analysed by appropriate molecular biological methods like 16S rRNA gene sequencing to gain insight into the composition of the gut microbiota.	4 weeks