The Effect of Probiotic Added to Maternal Diet on Infantile Colic and Intestinal Microbiota Content

NCT04374955 | Completed DMC

• 1 other identifier: a6pu2f37
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the effect of probiotic added to the diet of mothers on infantile colic in the postpartum period and the content of the neonatal intestinal microbiota.

Conditions

Infantile Colic; Microbial Colonization; Crying

Keywords

infantile colic, colic, probiotics, maternal diet, microbiota

Outcome Measures

Primary Outcomes (2)

• crying times

  reduction of ≥50% of mean daily crying duration. The mothers will provided with a diary(according to the Barr Baby Diary) and they will instructed on how to complete it daily with data concerning administration of daily dose of the study product, number and duration of crying episodes. In addition, mothers will be trained to use stopwatches. They will keep the crying times daily.

  up to 28 days

• microbiota analysis

  stool sample.

  up to 28 days

Secondary Outcomes (5)

• Mother's depression

  up to 28 days

• Binding

  up to 28 days

• Babies' height (cm) anthropometric evaluation

  up to 28 days

• weight (kg) anthropometric evaluation

  up to 28 days

• head circumference (cm) anthropometric evaluation

  up to 28 days

Study Arms (2)

İnfantile colic

EXPERIMENTAL

Mothers of babies diagnosed with infantile colic in the intervention group will receive routine care and start taking probiotic products after the first stool of the babies and blood is taken for intestinal permeability and will continue for 15 days.

Dietary Supplement: Activia Probiotics Shot; Other: Routine care

Control

OTHER

Mothers of babies diagnosed with infantile colic in the control group will receive routine care for 15 days after blood is taken for the first stool and intestinal permeability of the babies.

Other: Routine care

Interventions

Activia Probiotics Shot DIETARY_SUPPLEMENT

The product contains Actiregularis - at least 2x106 cfu / g.

İnfantile colic

Routine care OTHER

Routine care of the hospital will be provided.

Control; İnfantile colic

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Mother's ability to speak Turkish,
• Single pregnancy,
• Delivery time is between 37 \<GH \<42 weeks,
• The mother does not have a chronic disease,
• Vaginal birth,
• The mother's not using antibiotic drugs during pregnancy and postpartum period,
• Neonatal diagnosis of infantile colic,
• Scoring 10 points below the Beck Depression Inventory,
• Smoking of the woman during pregnancy and postpartum period,
• The absence of Intrauterine Growth Retardation (IUGR) or genetic disease in the newborn,
• Birth weight is in the range of 2500-4000 gr.
• No gastrointestinal disease in the newborn,
• % of the newborn is feeding on breast milk,
• No more than 24 hours of Early Membrane Rupture (EMR) at birth.

You may not qualify if:

• Having problems with the breast in the mother,
• The mother is using probiotics / antibiotics before randomization and during her pregnancy,
• Mothers who are included in the study sample, take part in other clinical studies at the same time.

Sponsors & Collaborators

• Halic University: lead
• Istanbul University - Cerrahpasa: collaborator

Study Sites (1)

Haseki Eğitim ve Araştırma Hastanesi

Istanbul, Sultangazi, 34096, Turkey (Türkiye)

Location

Related Publications (3)

• Yildiz Karaahmet A, Dolgun G, Ozen M, Oguz D. Effect of Maternal Probiotics on Infantile Colic Symptoms and Maternal Quality of Life and Maternal Attachment: A Single-Blind, Randomized Controlled Study. Altern Ther Health Med. 2025 Mar;31(2):18-22.

  PMID: 39715568 DERIVED

• Karaahmet AY, Dolgun G, Ozen M. Effects of probiotics on gastrointestinal symptoms, anthropometric measurements, and breastfeeding duration in infants with colic: a randomized control trial. Sao Paulo Med J. 2024 Apr 22;142(4):e2023069. doi: 10.1590/1516-3180.2023.0069.R1.31052023. eCollection 2024.

  PMID: 38655990 DERIVED

• Yildiz Karaahmet A, Dolgun G, Ozen M. Probiotics added to maternal nutrition affect infantile colic symptoms and fecal microbiota profile: a single-blind randomized controlled study. Clin Exp Pediatr. 2022 Nov;65(11):547-554. doi: 10.3345/cep.2022.00766. Epub 2022 Sep 23.

  PMID: 36229024 DERIVED

MeSH Terms

Conditions

Colic; Communicable Diseases; Crying

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nonverbal Communication; Communication; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: One-blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MsC

Model Details: One blind, Randomized controlled Trials

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 5, 2020
• Study Start: October 7, 2020
• Primary Completion: April 1, 2021
• Study Completion: June 1, 2021
• Last Updated: June 7, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: October 2021- June 2021

Locations

TU (1)