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| Name | Class |
|---|---|
| Ministry of Science and Innovation, Spain | OTHER_GOV |
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Randomized clinical trial to evaluate the effect of two probiotic strains which belong to Bifidobacterium Longum and Pediococcus pentosaceus species on fecal microbiota composition in healthy infants. Secondary outcomes comprise evaluation of anthropometric growth, digestive tolerance, sleeping habits, incidence of functional gastrointestinal disorders, incidence of gastrointestinal and respiratory infections, allergic reactions and safety and tolerability of the product.
Double-blind, randomized, placebo-controlled clinical trial to determine the effect of the probiotic strains Bifidobacterium longum and Pediococcus pentosaceus on fecal microbiota composition in infants. Healthy babies with ages comprised between 60 and 90 days who meet inclusion and exclusion criteria will be randomized 1:1:1 to one of the following study groups: one group will receive Bifidobacterium longum, another group will receive Pediococcus pentosaceus and the other one will receive placebo for 3 months. Other study outcomes comprise anthropometric growth, frequency and consistency of the stools, digestive tolerance, wellbeing, number, type and duration of infections and functional gastrointestinal disorders, and adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental 1 | Experimental | Probiotic single strain formulation comprising Bifidobacterium longum CECT7894 in liquid format suspended in sunflower oil. This probiotic strain has Qualified Presumption of Safety (QPS) status by European Food Safety Authority. |
|
| Experimental 2 | Experimental | Probiotic single strain formulation comprising Pediococcus pentosaceus CECT8330 in liquid format suspended in sunflower oil. This probiotic strain has Qualified Presumption of Safety (QPS) status by European Food Safety Authority. |
|
| Placebo | Placebo Comparator | Sunflower oil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Food Supplement 1 | Dietary Supplement | Probiotic single strain formulation containing Bifidobacterium longum CECT7894 for 3 months 5 drops/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Bifidobacterium longum and Pediococcus pentosaceus in feces | Change of total counts of Bifidobacterium longum and Pediococcus pentosaceus in feces determined by qPCR | day 0, month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Weight change | Change in weight (g per day) between day 0 and month 3 | day 0, month 1, month 2, month 3 |
| Length change | Change in length (cm) between day 0 and month 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gerardo Rodríguez Martínez, MD | Contact | 654633910 | +34 | gerard@unizar.es |
| Meritxell Aguilo Garcia, PhD | Contact | +34902903844 | aguilo@ab-biotics.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Nacional de Pediatría Insurgentes Sur 3700-C, Insurgentes Cuicuilco | Not yet recruiting | Alcaldía Coyoacán | Puebla | 04530 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34568236 | Background | Chen K, Liu C, Li H, Lei Y, Zeng C, Xu S, Li J, Savino F. Infantile Colic Treated With Bifidobacterium longum CECT7894 and Pediococcus pentosaceus CECT8330: A Randomized, Double-Blind, Placebo-Controlled Trial. Front Pediatr. 2021 Sep 10;9:635176. doi: 10.3389/fped.2021.635176. eCollection 2021. | |
| 21150647 | Background |
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| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Double-blind, randomized, placebo-controlled trial in 120 healthy infants between 1 and 90 days of age, who will be allocated to receive either one of the probiotic strains or placebo for 3 months
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Every product will be provided in identical packaging
| Food Supplement 2 | Dietary Supplement | Probiotic single strain formulation containing Pediococcus pentosaceus CECT8330 for 3 months 5 drops/day |
|
| Placebo | Dietary Supplement | 5 drops/day for 3 months of sunflower oil |
|
| day 0, month 1, month 2, month 3 |
| Head circumference change | Change in head circumference (cm) between day 0 and month 3 | day 0, month 1, month 2, month 3 |
| BMI change | Change in BMI (kg/m2) between day 0 and month 3 | day 0, month 1, month 2, month 3 |
| Frequency of depositions | Frequency of depositions (number stools/day) documented in participants diary | day 0, month 1, month 2, month 3 |
| Consistency of stools | Consistency of stools through a 5-item scale: 1= hard balls, 2=hard-formed, 3=soft-formed, 4=half liquid and 5=liquid | day 0, month 1, month 2, month 3 |
| Infant colic | Incidence of infant colic, defined as prolonged and recurrent periods of crying, agitation, or irritability without apparent cause that cannot be prevented or resolved by your caregivers, for three or more hours daily for three or more days a week | day 0, month 1, month 2, month 3 |
| Vomiting | Incidence of vomiting (n/day) | day 0, month 1, month 2, month 3 |
| Sleeping habits | Nocturnal sleeping (min/day), total sleeping hours (min/day) | day 0, month 1, month 2, month 3 |
| Incidence of infections | Number and duration (in days) of any type of infectious episodes | day 0, month 1, month 2, month 3 |
| Fever | Number of days with fever (axial body temperature higher than 37.5 ºC) | day 0, month 1, month 2, month 3 |
| Antibiotics | Number of days with antibiotic treatment | day 0, month 1, month 2, month 3 |
| Change in fecal microbiota composition | Analysis of α y β biodiversity, relative abundance of bacteria determined by 16S sequencing | day 0, month 3 |
| sIgA in stool samples | Analysis of secretory Immunoglobulin A (sIgA) in stools through ELISA | day 0, month 3 |
| Calprotectin | Analysis of fecal calprotectin through ELISA | day 0, month 3 |
| Clínica Viamed Montecanal | Recruiting | Zaragoza | Aragon | 50012 | Spain |
|
| Braegger C, Chmielewska A, Decsi T, Kolacek S, Mihatsch W, Moreno L, Piescik M, Puntis J, Shamir R, Szajewska H, Turck D, van Goudoever J; ESPGHAN Committee on Nutrition. Supplementation of infant formula with probiotics and/or prebiotics: a systematic review and comment by the ESPGHAN committee on nutrition. J Pediatr Gastroenterol Nutr. 2011 Feb;52(2):238-50. doi: 10.1097/MPG.0b013e3181fb9e80. |
| 32727119 | Background | Navarro-Tapia E, Sebastiani G, Sailer S, Toledano LA, Serra-Delgado M, Garcia-Algar O, Andreu-Fernandez V. Probiotic Supplementation During the Perinatal and Infant Period: Effects on Gut Dysbiosis and Disease. Nutrients. 2020 Jul 27;12(8):2243. doi: 10.3390/nu12082243. |
| 32443684 | Result | Castanet M, Costalos C, Haiden N, Hascoet JM, Berger B, Sprenger N, Grathwohl D, Brussow H, De Groot N, Steenhout P, Pecquet S, Benyacoub J, Picaud JC. Early Effect of Supplemented Infant Formulae on Intestinal Biomarkers and Microbiota: A Randomized Clinical Trial. Nutrients. 2020 May 20;12(5):1481. doi: 10.3390/nu12051481. |
| 26832746 | Result | Hoy-Schulz YE, Jannat K, Roberts T, Zaidi SH, Unicomb L, Luby S, Parsonnet J. Safety and acceptability of Lactobacillus reuteri DSM 17938 and Bifidobacterium longum subspecies infantis 35624 in Bangladeshi infants: a phase I randomized clinical trial. BMC Complement Altern Med. 2016 Feb 2;16:44. doi: 10.1186/s12906-016-1016-1. |
| 28002391 | Result | Radke M, Picaud JC, Loui A, Cambonie G, Faas D, Lafeber HN, de Groot N, Pecquet SS, Steenhout PG, Hascoet JM. Starter formula enriched in prebiotics and probiotics ensures normal growth of infants and promotes gut health: a randomized clinical trial. Pediatr Res. 2017 Apr;81(4):622-631. doi: 10.1038/pr.2016.270. Epub 2016 Dec 21. |