Observational Prospective Study With Probiotic Supplementation on Infants With FGDI

Functional Gastrointestinal Disorders Clinical Trial

Official title:

An Observational Prospective Study to Evaluate the Efficacy of 2 Weeks of Oral Supplementation With a Probiotic Formula in Infants With Functional Gastrointestinal Disorders (FGDI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04944628
• Other study ID #: Normocolic ADL
• Status: Completed
• Start date: August 15, 2018
• Est. completion date: December 5, 2018

Study information

• Verified date: June 2021
• Source: AB Biotics, SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This observational prospective study evaluates the safety, tolerability and efficacy of a probiotic formula in infants with functional gastrointestinal disorders (FGDI)

Description:

Functional gastrointestinal disorders (FGDIs) affect one out of two infants during the fist six months of life and do not have an organic cause. Infant colic, so-called excessive crying syndrome, and functional constipation are among the most common paediatric FGDIs. FGDIs pathophysiology is multifactorial and may include phycological factors and alterations of the gut physiology including gut microbiota dysbiosis. Probiotics are proposed as a potential treatment for FGDIs. However, evidence is limited. A probiotic formula composed of strains Bifidobacerium longum CECT 7894 and Pediococcus pentosaceus CECT 8330 is tested in this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 5, 2018
• Est. primary completion date: December 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 10 Months

Eligibility

Inclusion Criteria:

• Patients with gastrointestinal symptoms related to FGID including functional constipation and/or infant colic diagnosed according to Rome IV criteria for clinical purposes.
• = 37 weeks of gestation at birth.
• = 2500 g of birth weight.

Exclusion Criteria:

• Infants with failure to thrive (weight gain <100 grams/week on average from birth).
• Major medical problems (e. g. immunodeficiencies, developmental problems or genetic abnormalities)
• Gastrointestinal diseases
• Administered with antibiotics for 4 weeks or probiotics for 2 weeks before or during study

Related Conditions & MeSH terms

• Colic
• Constipation
• Digestive System Diseases
• Functional Constipation
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases
• Infantile Colic

Intervention

Dietary Supplement:
• Probiotic
Probiotic in liquid format (oil suspension) administered 10 drops once daily for 2 weeks (2x10^9 cfu/day)

Locations

Country	Name	City	State
Italy	Azienda Sanitaria Locale Napoli	Naples

Sponsors (1)

Lead Sponsor	Collaborator
AB Biotics, SA

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Benninga MA, Faure C, Hyman PE, St James Roberts I, Schechter NL, Nurko S. Childhood Functional Gastrointestinal Disorders: Neonate/Toddler. Gastroenterology. 2016 Feb 15. pii: S0016-5085(16)00182-7. doi: 10.1053/j.gastro.2016.02.016. [Epub ahead of print] — View Citation

Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in total FGDI severity	FGDI severity measured as summatory of excessive crying score (5-point Likert scale (0: no symptoms, to 4: extremely severe symptoms) + constipation score (5-point Likert scales (0: no symptoms, to 4: extremely severe symptoms)	Day 1 and day 14
Secondary	Change in excessive crying severity	Excessive crying score measured using 5-point Likert scales (0: no symptoms, to 4: extremely severe symptoms)	Day 1 and day 14
Secondary	Change in constipation severity	Constipation score measured using 5-point Likert scales (0: no symptoms, to 4: extremely severe symptoms)	Day 1 and day 14
Secondary	Change in parental anxiety	Recorded through the validated Generalized Anxiety Disorder (GAD) 7-item scale (GAD-7).	Day 1 and day 14
Secondary	Tolerability and safety	Any adverse events experienced throughout study period	Daily from day 1 to day 14
Secondary	Parental satisfaction with the product	Measured with a 5-point Likert scale (0: very dissatisfied, to 4: very satisfied)	Day 14