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Prebiotic EffecT InfanTs (PETIT)

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ClinicalTrials.gov Identifier: NCT04791956
Recruitment Status : Recruiting
First Posted : March 10, 2021
Last Update Posted : August 26, 2021
Sponsor:
Collaborators:
Hospital Universitari Sant Joan de Reus
Hospital de Tarragona Joan XXIII
Institut Investigacio Sanitaria Pere Virgili
Information provided by (Responsible Party):
Beneo-Institute

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

Condition or disease Intervention/treatment Phase
Infant Development Healthy Diet, Healthy Dietary Supplement: Prebiotic Dietary Supplement: Placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Double-blind, Randomized Placebo-controlled Trial Investigating the Effect of Prebiotic Inulin-type Fructans on Bowel Habits of Infants
Actual Study Start Date : March 17, 2021
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arms and Interventions
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Arm Intervention/treatment
Experimental: Prebiotic
Inulin-type fructans
 Dietary Supplement: Prebiotic
Daily intake of Inulin-type fructans from chicory
Placebo Comparator: Placebo
Maltodextrin
 Dietary Supplement: Placebo
Daily intake of maltodextrin


Outcome Measures
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Primary Outcome Measures :
  1. Stool consistency [ Time Frame: 4 weeks ]
    Assessed by the parents in a continuous daily bowel diary over the study period


Secondary Outcome Measures :
  1. Stool frequency [ Time Frame: 4 weeks ]
    Assessed by daily parental reporting

  2. Stool colour [ Time Frame: 4 weeks ]
    Assessed by the parents in a continuous daily bowel diary over the study period

  3. Stool amount [ Time Frame: 4 weeks ]
    Assessed by the parents in a continuous daily bowel diary over the study period

  4. Sleep [ Time Frame: 4 weeks ]
    Change in sleep behavior assessed by parental questionnaire (Brief Infant Sleep Questionnaire) at the beginning and end of the trial

  5. Stool pH [ Time Frame: 4 weeks ]
    change in stool pH over a four week period

  6. stool short-chain fatty acids [ Time Frame: 4 weeks ]
    change in amount and relative distribution of short-chain fatty acids in stool over a four week period

  7. Tolerance and acceptability [ Time Frame: 4 weeks ]
    Tolerance and acceptability of the study products assessed by customized parental questionnaire at the end of the trial

  8. Body weight [ Time Frame: 4 weeks ]
    changes in body weight (kg) assessed by an investigator

  9. Body height [ Time Frame: 4 weeks ]
    changes in body height (m) assessed by an investigator

  10. Faecal Microbiota [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   6 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04791956


Contacts
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Contact: Stephan Theis, PhD +49 6359 803 287 stephan.theis@beneo.com

Locations
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Spain
Hospital Universitari Sant Joan de Reus - Magatzem Recruiting
Reus, Spain, 43204
Contact: Carme Rubio         
Hospital Universitari Joan XXIII de Tarragona - Almacén general Recruiting
Tarragona, Spain, 43005
Contact: Mariona Gispert         
Sponsors and Collaborators
Beneo-Institute
Hospital Universitari Sant Joan de Reus
Hospital de Tarragona Joan XXIII
Institut Investigacio Sanitaria Pere Virgili
Investigators
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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
More Information
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Publications:

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Responsible Party: Beneo-Institute
ClinicalTrials.gov Identifier: NCT04791956    
Other Study ID Numbers: 20018m-jhr
First Posted: March 10, 2021    Key Record Dates
Last Update Posted: August 26, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Beneo-Institute:
Microbiota, gastrointestinal health