Assessment of the Impact of Type of Probiotic, Delivery Type and Feeding Type on Baby's Microbiota After Dysbiotic Delivery

Dysbiosis Clinical Trial

Official title:

Assessment of the Impact of Type of Probiotic, Delivery Type and Feeding Type on Baby's Microbiota After Dysbiotic Delivery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04304014
• Other study ID #: Pro-Care 3
• Status: Recruiting
• Phase: N/A
• Start date: March 5, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: Fundacion Clinic per a la Recerca Biomédica
• Contact: García-Algar Óscar, PhD
• Phone: 0034 932275607
• Email: ogarciaa[@]clinic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Week

Eligibility

Inclusion Criteria:

• Healthy infants in their first week of life

• Infants with adequate weight according to the gestational age.

• Infants born by vaginal delivery whose mother was given antimicrobial prophylaxis or infants born by C-section.

• Gestational birth equal or greater than 37 weeks.

• Exclusive or almost exclusive breastfeeding - understanding almost exclusive the one in which there is a maximum of one formula dose per day - or mixt breastfeeding, the one in which there are more than one formula dose per day.

Exclusion Criteria:

• Infants with smoker mother during pregnancy and after delivery.

• Infants whose parents cannot follow the study requirements

• Infants who have suffered neonatal admission or have suffered or suffer necrotizing enterocolitis, infectious disease, congenital malformation, short bowel syndrome or any serious illness.

• Infants who have taken probiotics before the start of the trial or who take formula with probiotics.

• Breast-fed infants whose mothers have taken probiotics within the two weeks before study inclusion.

• Infants who ingest special formulas as extensively hydrolysed formulas.

• Breast-fed infants whose mothers have excluded dairy products and egg products in their diet during breastfeeding

• Infants who take specific medication for the treatment of functional digestive disorders: antacids (type IBP or H2 blockers), laxatives (PEG, lactulose, magnesia), lactase and simethicone at the time of inclusion.

• Infants undergoing therapies with acupuncture, homeopathy, medicinal herbs, anti-inflammatories and antispasmodics at the time of inclusion.

Related Conditions & MeSH terms

• Dysbiosis

Intervention

Dietary Supplement:
• L. reuteri
(10^8 CFU) once a day
• B. longum and P. Pentosaceus
(10^9 CFU) once a day

Locations

Country	Name	City	State
Spain	Neonatal Unit, Hospital Clinic-Maternitat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion Clinic per a la Recerca Biomédica

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metagenomic analysis of gut microbiota	The achievement of a microbiota dominated by Bacteroides, Lactobacillus and Bifidobacterium, along with a decrease in Enterobacteria after 4 weeks of probiotic treatment. Faecal sampleswill be collected at baseline and 1 month after probiotic treatment.	1 month
Secondary	Number of regurgitations by questionnaire included in patients' diary	Number of regurgitations will be documented by the parents each week for 3 months in patients diary	3 months
Secondary	Number of constipation episodes by questionnaire included in patients' diary	Number of constipation episodes will be documented by the parents each week for 3 months in patients' diary	3 months
Secondary	Number of infant colic episodes by questionnaire included in patients' diary	Number of constipation episodes will be documented by the parents each week for 3 months in patient's diary	3 months
Secondary	Metagenomic analysis of total gut microbiota	This measure includes all bacteria detected in feaces by metagenomic analysis. Faecal samples will be collected at baseline and 1 month after probiotic treatment.	1 month
Secondary	Respiratory, gastrointestinal infections and use of medication by questionnaire included in patients' diary	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	3 months
Secondary	Anxiety and depression by the validated Hospital Anxiety and Depression scale (HADS)	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	3 months
Secondary	Extra visits to paediatrician/emergency by questionnaire included in the patient's diary	Number of paediatric visits and / or emergency access will be documented each week in the patient's diary during the 3 months of treatment	3 months
Secondary	Number of Participants With Treatment-Related Adverse Events	Adverse events will be documented weekly in the patient's diary during the 3 months of treatment.	3 months
Secondary	Levels of IgA in faeces	changes in IgA in faeces from baseline to 1 month of treatment	1 month
Secondary	Weight evolution by the paedatrician in study visits	Changes on baby's body weight from baseline to 3 months of probiotic treatment	3 months