L. reuteri
Dietary Supplement(10^8 CFU) once a day
NCT Number: NCT04304014
This study aims to determine the effect of three factors (delivery type, feeding type and the use of two different dietary supplements) on rebiosis after disbiotic delivery. This is a randomized, single-blinded study with two parallel arms. Group 1 will receive L. reuteri (10^8 CFU) once a day, group 2 will receive B. longum and P. Pentosaceus (10^9 CFU) once a day.
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All sexes
Interventional
Not applicable
Hospital Universitari General de Catalunya, Sant Cugat del Vallès, Barcelona, Spain
Gut colonization during the first days of life represents the start of the infant's own microbiota. This process is influenced by different factors: delivery type, feeding type, antibiotic treatment, etc. On the one hand, vaginally delivered babies are in contact with mother's vaginal and faecal microbiota. This fact will drive a neonatal gut colonization composed of vagina-associated bacteria. In contrast, babies born by C-section are more susceptible to be colonized by microorganisms present in the mother's skin. On the other hand, antibiotic administration during vaginal delivery also produces alterations in the vaginal microbiota of the mother. Described scenarios have been correlated to immunological and metabolic diseases such as asthma, allergies, diabetes or obesity. Moreover, disbiosis has also been associated to functional gastrointestinal disorders (FGID) in babies such as infant colic and functional constipation. After a disbiotic delivery, medical doctors usually recommend the use of probiotics to prevent rebiosis. Since the probiotics.
L. reuteri, and B. longum and P. Pentosaceus have shown efficacy on FGID amelioration in previously published articles, these two probiotics were selected for the present study. All together, this study aims to characterize the role of three different parameters: type of probiotic, delivery type and feeding type.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
(10^8 CFU) once a day
(10^9 CFU) once a day
Time frame: 1 month
Changes in the relative abundance of bifidobacteria in stool microbiota after 1 month of supplementation, measured with metagenomic techniques.
Time frame: 3 months
Number of regurgitations will be documented by the parents each week for 3 months in patients diary
Time frame: 3 months
Number of constipation episodes will be documented by the parents each week for 3 months in patients' diary
Time frame: 3 months
Number of constipation episodes will be documented by the parents each week for 3 months in patient's diary
Time frame: 1 month
This measure includes all bacteria detected in feaces by metagenomic analysis. Faecal samples will be collected at baseline and 1 month after probiotic treatment. Analysis will comprise changes in the relative abundance of B. longum and P. Pentosaceous as well as in other bacterial groups common in the infant gut. In addition, the proportion (Bifidobacterium + Lactobacillus + Bacteroides) will be determined
Time frame: 3 months
Number of respiratory, gastrointestinal infections and use of medication episodes will be documented by the parents each week for 3 months in patient's diary
Time frame: 3 months
Anxiety and depression levels of the father and mother will be evaluated at baseline and 3 months after probiotic treatment through the Hospital Anxiety and Depression Scale (HADS) questionnaire will be.
Odd questions (assess anxiety). Even questions (assess depression). Score less than or equal to 7 = no case. 8-10 = doubtful case Score equal to or greater than 11 = case
Time frame: 3 months
Number of paediatric visits and / or emergency access will be documented each week in the patient's diary during the 3 months of treatment
Time frame: 3 months
Adverse events will be documented weekly in the patient's diary during the 3 months of treatment.
Time frame: 1 month
changes in IgA in faeces from baseline to 1 month of treatment
Time frame: 3 months
Changes on baby's body weight from baseline to 3 months of probiotic treatment
Fundacion Clinic per a la Recerca Biomédica
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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