Gastrointestinal Tolerance and Safety of an Infant Formula Containing Prebiotics, Probiotics and Postbiotics.

NCT04745455 | Completed

• 1 other identifier: SBB20R&32116
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 3

Brief Summary

A study to investigate the gastrointestinal tolerance and safety of a new formula containing prebiotics, probiotics and postbiotics.

Conditions

Gastrointestinal Tolerance

Outcome Measures

Primary Outcomes (5)

• Gastrointestinal tolerance

  A 13-item questionnaire where each item is scored on a scale of 1 to 5 with higher values indicating greater GI distress.

  Baseline

• Gastrointestinal tolerance

  A 13-item questionnaire where each item is scored on a scale of 1 to 5 with higher values indicating greater GI distress.

  Day 7

• Gastrointestinal tolerance

  A 13-item questionnaire where each item is scored on a scale of 1 to 5 with higher values indicating greater GI distress.

  Day 14

• Gastrointestinal tolerance

  A 13-item questionnaire where each item is scored on a scale of 1 to 5 with higher values indicating greater GI distress.

  Day 21

• Gastrointestinal tolerance

  A 13-item questionnaire where each item is scored on a scale of 1 to 5 with higher values indicating greater GI distress.

  Day 28

Secondary Outcomes (11)

• Stool consistency

  Baseline

• Stool consistency

  Day 7

• Stool consistency

  Day 14

• Stool consistency

  Day 21

• Stool consistency

  Day 28

Other Outcomes (4)

• Well being questionnaire

  Baseline

• Well being questionnaire

  Day 28

• Study product appreciation questionnaire;

  Day 7

Study Arms (1)

Cow's milk based infant formula containing prebiotics, probiotics and postbiotics

OTHER

Other: Infant formula containing prebiotics, probiotics and postbiotics

Interventions

Infant formula containing prebiotics, probiotics and postbiotics OTHER

Infant formula containing prebiotics, probiotics and postbiotics

Cow's milk based infant formula containing prebiotics, probiotics and postbiotics

Eligibility Criteria

• Age: 14 Days - 84 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Term infants with a gestational age at birth of ≥37 weeks + 0 days and ≤41 weeks + 6 days;
• Singleton, healthy infants as judged by the principle investigator;
• Infants with age at screening ≥2 weeks (14 days) and ≤ 12 weeks (84 days)
• Infants who are fully formula fed for at least 1 week prior to screening and whose parents have autonomously decided to fully formula feed, i.e. not to breastfeed or have ended breastfeeding, and who are intending to fully formula feed;
• Written informed consent from the parent(s) and/or legally acceptable representative(s), aged ≥ 18 years.

You may not qualify if:

• Infants who require to be fed a special diet other than standard cow's milk-based infant formula;
• Infants known to have or suspected to have cow's milk protein allergy, lactose intolerance, or galactosaemia including history of any other allergic manifestations or known allergy to any of the study product ingredients;
• Infants with known or suspected congenital diseases or malformations which could interfere with the study or its outcome parameters, such as but not limited to: GI malformations, congenital metabolic disorders, severe congenital cardiac disorders, immunodeficiency or major surgery, as per the clinical judgment of the Investigator;
• Infants diagnosed with a gastrointestinal infection within 4 weeks prior to screening;
• Infants with current or previous illnesses/conditions or interventions which could interfere with the study or its outcome parameters (e.g. diarrhea requiring treatment, constipation requiring treatment, regurgitation requiring treatment, dental/medical procedures which may impact oral feeding), as per the clinical judgment of the Investigator;
• Received any of the following products/medication prior to screening: systemic antibiotics, prokinetics, proton pump inhibitors, prebiotic supplements, probiotic supplements, complementary feeding/weaning within 4 weeks prior to screening;
• Incapability of infants' parents to comply with study protocol as per the judgment of the Investigator (e.g. fluency in local language, access to laptop/smartphone devices and internet connection required for data collection);
• Infants with previous, current or intended participation in any other clinical study involving investigational or marketed products concomitantly or prior to study.

Sponsors & Collaborators

• Nutricia Research: lead

Study Sites (3)

Poliklinika Ginekologiczno-Poloznicza Sp. Z.O.O Sp.K

Bialystok, 15-435, Poland

Location

Izabela Tarczoń Przylądek Zdrowia Specjalistyczne Poradnie Medyczne

Krakow, 30-324, Poland

Location

NZLA Michalkowice Jarosz i partnerzy Spolka

Siemianowice Śląskie, 41-103, Poland

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: February 9, 2021
• Study Start: January 22, 2021
• Primary Completion: July 12, 2021
• Study Completion: July 12, 2021
• Last Updated: January 25, 2022

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (3)