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

Gastrointestinal Tolerance Clinical Trial

— TREE  

Official title:

An Open-label Single-arm Study to Investigate Gastrointestinal Tolerance, Safety, and Acceptability of a New Infant Formula Containing Prebiotics, Probiotics and Postbiotics, in Healthy Term Infants.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04745455
• Other study ID #: SBB20R&32116
• Status: Completed
• Phase: N/A
• Start date: January 22, 2021
• Est. completion date: July 12, 2021

Study information

• Verified date: January 2021
• Source: Nutricia Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: July 12, 2021
• Est. primary completion date: July 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 84 Days

Eligibility

Inclusion Criteria:

1. Term infants with a gestational age at birth of =37 weeks + 0 days and =41 weeks + 6 days;

2. Singleton, healthy infants as judged by the principle investigator;

3. Infants with age at screening =2 weeks (14 days) and = 12 weeks (84 days)

4. 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;

5. Written informed consent from the parent(s) and/or legally acceptable representative(s), aged = 18 years.

Exclusion Criteria:

1. Infants who require to be fed a special diet other than standard cow's milk-based infant formula;

2. 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;

3. 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;

4. Infants diagnosed with a gastrointestinal infection within 4 weeks prior to screening;

5. 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;

6. 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;

7. 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);

8. Infants with previous, current or intended participation in any other clinical study involving investigational or marketed products concomitantly or prior to study.

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Related Conditions & MeSH terms

• Gastrointestinal Tolerance

Intervention

Other:
• Infant formula containing prebiotics, probiotics and postbiotics
Infant formula containing prebiotics, probiotics and postbiotics

Locations

Country	Name	City	State
Poland	Poliklinika Ginekologiczno-Poloznicza Sp. Z.O.O Sp.K	Bialystok
Poland	Izabela Tarczon Przyladek Zdrowia Specjalistyczne Poradnie Medyczne	Kraków
Poland	NZLA Michalkowice Jarosz i partnerzy Spolka	Siemianowice-Slaskie

Sponsors (1)

Lead Sponsor	Collaborator
Nutricia Research

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Well being questionnaire	A parent reported 3-item questionnaire with individual scores from 1-5 (strongly agree, agree, neither agree nor disagree, disagree, strongly disagree)	Baseline
Other	Well being questionnaire	A parent reported 3-item questionnaire with individual scores from 1-5 (strongly agree, agree, neither agree nor disagree, disagree, strongly disagree)	Day 28
Other	Study product appreciation questionnaire;	A parent reported evaluation of product characteristics with a categorical rating scale and open questions	Day 7
Other	Study product appreciation questionnaire;	A parent reported evaluation of product characteristics with a categorical rating scale and open questions	Day 28
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Stool consistency	Parent reported daily stool consistency using stool scales with categories 1; watery, 2; loose, 3; formed, 4; hard	Baseline
Secondary	Stool consistency	Parent reported daily stool consistency using stool scales with categories 1; watery, 2; loose, 3; formed, 4; hard	Day 7
Secondary	Stool consistency	Parent reported daily stool consistency using stool scales with categories 1; watery, 2; loose, 3; formed, 4; hard	Day 14
Secondary	Stool consistency	Parent reported daily stool consistency using stool scales with categories 1; watery, 2; loose, 3; formed, 4; hard	Day 21
Secondary	Stool consistency	Parent reported daily stool consistency using stool scales with categories 1; watery, 2; loose, 3; formed, 4; hard	Day 28
Secondary	Stool frequency	Parent reported daily number of stools	Baseline
Secondary	Stool frequency	Parent reported daily number of stools	Day 7
Secondary	Stool frequency	Parent reported daily number of stools	Day 14
Secondary	Stool frequency	Parent reported daily number of stools	Day 21
Secondary	Stool frequency	Parent reported daily number of stools	Day 28
Secondary	Incidence, frequency, and severity of (S)AEs, and relatedness to study product of (Serious) Adverse Events.	(S)AE collection	Through study completion, an average of one month