Prebiotic EffecT InfanTs (PETIT)

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

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

Study Overview

• Status: Recruiting
• Conditions: Healthy; Diet, Healthy; Infant Development
• Intervention / Treatment: Dietary supplement: Prebiotic; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephan Theis, PhD; Phone Number: +49 6359 803 287; Email: stephan.theis@beneo.com

Study Locations

• Spain
  • Reus, Spain, 43204
    • Recruiting
    • Hospital Universitari Sant Joan de Reus - Magatzem
    • Contact: Carme Rubio
  • Tarragona, Spain, 43005
    • Recruiting
    • Hospital Universitari Joan XXIII de Tarragona - Almacén general
    • Contact: Mariona Gispert

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 1 year (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Maltodextrin	Dietary supplement: Placebo; Daily intake of maltodextrin
Experimental: Prebiotic; Inulin-type fructans	Dietary supplement: Prebiotic; Daily intake of Inulin-type fructans from chicory

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stool consistency	Assessed by the parents in a continuous daily bowel diary over the study period	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stool frequency	Assessed by daily parental reporting	4 weeks
Stool colour	Assessed by the parents in a continuous daily bowel diary over the study period	4 weeks
Stool amount	Assessed by the parents in a continuous daily bowel diary over the study period	4 weeks
Sleep	Change in sleep behavior assessed by parental questionnaire (Brief Infant Sleep Questionnaire) at the beginning and end of the trial	4 weeks
Stool pH	change in stool pH over a four week period	4 weeks
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
Tolerance and acceptability	Tolerance and acceptability of the study products assessed by customized parental questionnaire at the end of the trial	4 weeks
Body weight	changes in body weight (kg) assessed by an investigator	4 weeks
Body height	changes in body height (m) assessed by an investigator	4 weeks
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

Collaborators and Investigators

• Sponsor: Beneo-Institute
• Collaborators: Institut Investigacio Sanitaria Pere Virgili; Hospital Universitari Sant Joan de Reus; Hospital de Tarragona Joan XXIII
• Investigators: Principal Investigator: Ricardo Closa Monasterolo, Phd, MD, Paediatrics Unit, University Hospital Joan XXIII, Tarragona, Spain. Paediatrics Research Unit on Nutrition and Human Development, Universitat Rovira i Virgili, Reus, Spain; Principal Investigator: Joaquin Escribano Subias, PhD, MD, Paediatrics Unit, University Hospital Sant Joan, Reus, Spain. Paediatrics Research Unit on Nutrition and Human Development, Universitat Rovira i Virgili, Reus, Spain

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2021
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: March 5, 2021
• First Submitted That Met QC Criteria: March 9, 2021
• First Posted (Actual): March 10, 2021

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Microbiota, gastrointestinal health
• Other Study ID Numbers: 20018m-jhr

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No