Prebiotic EffecT InfanTs

Not Applicable

Recruiting

• Conditions: Healthy; Diet, Healthy; Infant Development
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Prebiotic

• Registration Number: NCT04791956
• Lead Sponsor: Beneo-Institute

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2021-03-05
• Study First Submitted QC: 2021-03-09
• Study First Posted: 2021-03-10
• Study Start: 2021-03-17
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-12
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Maltodextrin
Prebiotic	Prebiotic	Inulin-type fructans

Primary Outcome Measures

Name	Time	Method
Stool consistency	4 weeks	Assessed by the parents in a continuous daily bowel diary over the study period

Secondary Outcome Measures

Name	Time	Method
Stool amount	4 weeks	Assessed by the parents in a continuous daily bowel diary over the study period
Sleep	4 weeks	Change in sleep behavior assessed by parental questionnaire (Brief Infant Sleep Questionnaire) at the beginning and end of the trial
Stool colour	4 weeks	Assessed by the parents in a continuous daily bowel diary over the study period
Body weight	4 weeks	changes in body weight (kg) assessed by an investigator
Body height	4 weeks	changes in body height (m) assessed by an investigator
Faecal Microbiota	4 weeks	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.
Stool frequency	4 weeks	Assessed by daily parental reporting
Tolerance and acceptability	4 weeks	Tolerance and acceptability of the study products assessed by customized parental questionnaire at the end of the trial
Stool pH	4 weeks	change in stool pH over a four week period
stool short-chain fatty acids	4 weeks	change in amount and relative distribution of short-chain fatty acids in stool over a four week period

Trial Locations

Locations (2)

Hospital Universitari Joan XXIII de Tarragona - Almacén general; 🇪🇸 Tarragona, Spain

Hospital Universitari Sant Joan de Reus - Magatzem; 🇪🇸 Reus, Spain