Probiotic Supplement Clinical Trial
Official title:
Growth, Safety and Efficacy of a Probiotic Supplement: a Double-blind, Randomized, Placebo-controlled Trial
| Verified date | March 2023 |
| Source | Société des Produits Nestlé (SPN) |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The primary objective of the study is to demonstrate the safety of a daily high dose of a probiotic supplement by comparing the growth (weight gain, g/day) of formula-fed and/or breastfed infants in high dose group versus placebo group from enrolment to 8 weeks of intervention
| Status | Completed |
| Enrollment | 228 |
| Est. completion date | October 12, 2021 |
| Est. primary completion date | August 23, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 14 Days to 21 Days |
| Eligibility | Inclusion Criteria: 1. Evidence of personally signed and dated informed consent document indicating that the infant's parent(s)/ legally accepted representatives LAR have been informed of all pertinent aspects of the study. 2. Infants whose parent(s)/LAR have reached the legal age of majority in the countries where the study is conducted. 3. Infants whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the study protocol. 4. Infants whose parent(s)/LAR can be contacted directly by telephone throughout the study. 5. Infants whose parent(s)/LAR have access to a working freezer. 6. Infants must meet all the following inclusion criteria to be eligible for enrolment into the study: 1. Healthy term (37-42 weeks of gestation) infant at birth. 2. At enrolment visit, post-natal age 14-21 days (date of birth = day 0) 3. Birth weight = 2500g and = 4500g. 4. Breastfed and/or formula-fed infants (including exclusively and mixed fed breast- and formula-fed infants) whose parent(s)/LAR intent not to change the feeding regimen until the study end at 8 weeks of intervention. 5. Formula-fed infants and their parent(s)/LAR must have independently elected, before enrolment not to breastfeed and their infant must tolerate a standard cow's milk infant formula not containing any probiotics at time of enrolment. Exclusion Criteria: 1. Infants with conditions requiring specific infant feeding regimens other than those specified in the protocol. 2. Infants receiving complementary foods or liquids defined as 4 or more teaspoons per day or approximately 20 g per day of complementary foods or liquids at or prior to enrollment. 3. Infants who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results, including: 1. Evidence of major congenital malformations (e.g., cleft palate, extremity malformation). 2. Suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis). 3. History of admission to the Neonatal Intensive Care Unit (NICU), except for admission for jaundice phototherapy. 4. Other severe medical or laboratory abnormality (acute or chronic) which, in the judgment of the investigator, would make the infant inappropriate for entry into the study. 4. Infants who are presently receiving or have received prior to enrollment probiotic supplements or any of the following: medication(s) or supplement(s) which are known or suspected to affect the following: fat digestion, absorption, and/or metabolism (e.g., pancreatic enzymes); stool characteristics (e.g., glycerin suppositories, bismuth-containing medications, docusate, Maltsupex, or lactulose); growth (e.g. insulin or growth hormone); gastric acid secretion. 5. Currently participating or having participated in another clinical trial since birth. |
| Country | Name | City | State |
|---|---|---|---|
| Philippines | Asian Foundation for Tropical Medicine, Inc. | Muntinlupa |
| Lead Sponsor | Collaborator |
|---|---|
| Société des Produits Nestlé (SPN) |
Philippines,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Additional growth parameters: weight | Weight in grams and corresponding weight-for-age Z-score according WHO growth standards | Day 0, Day 28, Day 56 | |
| Other | Additional growth parameters: length | Length in centimeters and corresponding length-for-age Z-score according WHO growth standards | Day 0, Day 28, Day 56 | |
| Other | Additional growth parameters: head circumference | Head circumference in centimeters and corresponding head circumference-for-age Z-score according WHO growth standards | Day 0, Day 28, Day 56 | |
| Other | Additional growth parameters: body mass index | BMI and corresponding BMI-for-age Z-score according WHO growth standards | Day 0, Day 28, Day 56 | |
| Other | Fecal microbiome composition | Overall fecal microbiota composition, diversity, and microbiota community types will be assessed using NGS technology (including relative abundance of beneficial bifidobacteria bacteria species and pathogenic bacteria species) and | Day 0, Day 28, Day 56 | |
| Other | Bifidobacteria colonization | Bifidobacteria colonization using a newly developed rapid diagnostic kit | Day 0, Day 28, Day 56 | |
| Other | Fecal microbiome: Continuation of bifidobacteria colonization | Continuation of bifidobacteria colonization 4 weeks after intervention stop using NGS technology and DNAFoil® technology | Day 84 | |
| Other | Fecal metabolic profile: Fecal pH | Fecal pH | Day 0, Day 28, Day 56 | |
| Other | Fecal metabolic profile: Fecal organic acids | Fecal organic acids (such as, but not restricted to lactate, propionate, butyrate, acetate, valerate, and total fecal organic acids) | Day 0, Day 28, Day 56 | |
| Other | Fecal metabolic profile: gut microbiota-derived metabolites | Concentration of gut microbiota-derived metabolites using mass spectrometry and/or nuclear magnetic resonance | Day 0, Day 28, Day 56 | |
| Other | Biological response of selected fecal metabolites | Biological response using cultured cell lines or combinations of cell lines (Cell-based functional assays) | Day 0, Day 28, Day 56 | |
| Other | Fecal markers of immune health and gut barrier | Total secretory IgA, calprotectin, and a-1-antitrypsin assessed by ELISA and Fecal cytokine levels (such as, but not restricted to: IL-1ra, IL-1a, IL-1ß, IL-6, IFN- ?, and TNF-a) will be measured by multiplex assays | Day 0, Day 28, Day 56 | |
| Other | GI tolerance | Infant Gastrointestinal Symptom Questionnaire (IGSQ-13) Index Score for overall GI tolerance calculated from the IGSQ-13 | Day 0, Day 28, Day 56 | |
| Other | GI-related behaviors: Stool frequency | GI endpoints will be recorded via the 1-day and 3-day GI Symptom and Behavior Diary | Day 0, Day 25-27, Day 53-55 | |
| Other | GI-related behaviors: Stool consistency | Stool consistency using a validated 5-point scale in the 1-day and 3-day GI Symptom and Behavior Diary | Day 0, Day 25-27, Day 53-55 | |
| Other | GI-related behaviors: Incidence of spitting-up | Incidence of spitting-up using a Likert scale via the 1-day and 3-day GI Symptom and Behavior Diary | Day 0, Day 25-27, Day 53-55 | |
| Other | GI-related behaviors: Incidence of flatulance | Flatulence of spitting-up using a Likert scale via the 1-day and 3-day GI Symptom and Behavior Diary | Day 0, Day 25-27, Day 53-55 | |
| Other | GI-related behaviors: Crying time | Crying time (hours/min) via the 1-day and 3-day GI Symptom and Behavior Diary | Day 0, Day 25-27, Day 53-55 | |
| Other | GI-related behaviors: Sleep time | Sleep time (hours/min) using a Likert scale via the 1-day and 3-day GI Symptom and Behavior Diary | Day 0, Day 25-27, Day 53-55 | |
| Primary | Safety of high dose probiotic supplement (weight gain) | Compare the growth (weight gain, g/day) of formula-fed and/or breastfed infants in EG 1 vs. CG from enrolment to 8 weeks of intervention | Day 56 | |
| Secondary | Efficacy of two different doses of probiotic supplement | Bifidobacteria abundance measured in the fecal sample collected at home after 8 weeks of intervention (V3) analyzed by next generation sequencing (NGS) technology. | Day 0, Day 25-27, Day 53-55 |