Effects of Multilac Baby on Fecal Calprotectin Levels of Colicky Babies

NCT04666324 | Unknown

• 1 other identifier: Kalisz 2020-02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

Open trial with two parallel arms, assessing the effects of Simethicone and Multilac Baby on crying behavior and fecal calprotectin levels in babies diagnosed for infantile colic.

Conditions

Infantile Colic

Outcome Measures

Primary Outcomes (3)

• Change of days of crying

  Measurement of days of crying during last three weeks before enrollment and before the end of treatment. Treatment success will be determined by calculation the percentage of patients for whom the measurement will be reduced by the respective treatment by equal or more than 50 percent, compared to the value at the time of enrollment.

  Three weeks

• Change of average duration of evening crying

  Measurement of average duration of evening crying during last three weeks before enrollment and before the end of treatment. Treatment success will be determined by calculation the percentage of patients for whom the measurement will be reduced by the respective treatment by equal or more than 50 percent, compared to the value at the time of enrollment.

  Three weeks

• Change of fecal calprotectin values

  BÜHLMANN Quantum Blue® Calprotectin High Range (Schönenbuch, Switzerland). It is a quantitative determination of fecal calprotectin through a sandwich immunoassay. Treatment success will be determined by calculation the percentage of patients for whom the measurement will be reduced by the respective treatment by equal or more than 50 percent, compared to the value at the time of enrollment.

  1-30 days

Study Arms (2)

Simethicone Solution

ACTIVE COMPARATOR

Treatment with simethicone (Espumisan®, 100 mg/ml, Berlin-Chemie / Menarini Polska Sp z o.o., Warsaw, Poland) for four weeks. Simethicone was administered 3-6 times per day with each treatment comprising 6 drops of the 100 mg/ml emulsion.

Drug: Simethicone Solution

Multilac Baby

EXPERIMENTAL

Treatment with one stick pack of the multi-strain synbiotic (Multilac® Baby, Vivatrex GmbH, Aachen, Germany) per day for four weeks. Each stick pack of Multilac® Baby contains a total of 10\^9 colony forming units (CFU) with equal CFU amounts of the following probiotic bacteria: L. acidophilus LA-14, L. casei R0215; L. paracasei Lpc-3; L. plantarum Lp-115; L. rhamnosus GG, L. salivarius Ls-33, B. lactis Bl-04, B. bifidum R0071, B. longum R0175 and 1.43 g of the prebiotic fructooligosaccharides.

Dietary Supplement: Multilac Baby

Interventions

Simethicone Solution DRUG

Oral daily treatment for four weeks

Also known as: Control Group

Simethicone Solution

Multilac Baby DIETARY_SUPPLEMENT

Oral daily treatment for four weeks

Also known as: Treatment Group

Multilac Baby

Eligibility Criteria

• Age: 3 Weeks - 6 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• diagnosed for infantile colic according to Wessel's criteria

You may not qualify if:

• previous treatment with probiotic or synbiotic
• previous treatment with antibiotics

Sponsors & Collaborators

• The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz: lead

Study Sites (2)

GP Clinic "Panaceum"

Brody, 27-230, Poland

Location

GP Clinic "Pro Familia"

Koziegłowy, 62028, Poland

Location

Related Publications (3)

• Piatek J, Krauss H, Ciechelska-Rybarczyk A, Bernatek M, Wojtyla-Buciora P, Sommermeyer H. In-Vitro Growth Inhibition of Bacterial Pathogens by Probiotics and a Synbiotic: Product Composition Matters. Int J Environ Res Public Health. 2020 May 11;17(9):3332. doi: 10.3390/ijerph17093332.

  PMID: 32403297 RESULT

• Sommermeyer H, Bernatek M, Pszczola M, Krauss H, Piatek J. Supporting the diagnosis of infantile colic by a point of care measurement of fecal calprotectin. Front Pediatr. 2022 Sep 29;10:978545. doi: 10.3389/fped.2022.978545. eCollection 2022.

  PMID: 36245729 DERIVED

• Bernatek M, Piatek J, Pszczola M, Krauss H, Antczak J, Maciukajc P, Sommermeyer H. Nine-Strain Bacterial Synbiotic Improves Crying and Lowers Fecal Calprotectin in Colicky Babies-An Open-Label Randomized Study. Microorganisms. 2022 Feb 12;10(2):430. doi: 10.3390/microorganisms10020430.

  PMID: 35208884 DERIVED

Related Links

• Publication

MeSH Terms

Conditions

Colic

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Hanna Krauss, Prof.

  The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanna i Krauss, Prof.

CONTACT

+48 88 33 89; hjk12@pczta.fm

Jacek Piatek, Prof.

CONTACT

drpiatek@interia.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 14, 2020
• Study Start: December 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: September 1, 2021
• Last Updated: December 14, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2)