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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04944628
Other study ID # Normocolic ADL
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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