Infantile ColicNCT04666324
Effects of Multilac Baby on Fecal Calprotectin Levels of Colicky Babies
A study testing Simethicone Solution and Multilac Baby in people with Infantile Colic, run by The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz at 2 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 6 weeks
- Conditions the study is for
- Infantile Colic
- What is being tested?
- Simethicone Solution and Multilac Baby
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesPoland
- Study dates
- Dec 2020to Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- diagnosed for infantile colic according to Wessel's criteria
Who cannot join
- previous treatment with probiotic or synbiotic
- previous treatment with antibiotics
Trial locations and contacts
2 sites in 1 country.
Jacek Piatek, Prof. contact
Poland2 sites
GP Clinic "Panaceum"
Brody, 27-230
Marek Maciukajc, Dr., marek.maciukajc@gmail.com
Jacek Piatek, Prof., drpiatek@interia.eu
GP Clinic "Pro Familia"
Koziegłowy, 62028
Hanna Krauss, Prof., hjk12@pczta.fm
Jacek Piatek, Prof., drpiatek@interia.eu
About this study
Official title: Effects of Simethicone and Multilac Baby on Fecal Calprotectin Levels Infantile Colic
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.
Read the detailed description
Babies aged 3 to 6 weeks will be diagnosed for infantile colic using the Wessel's criteria. Study design will be open label with two parallel arms (Simethicone and Multilac Baby). Multilac Baby is a synbiotic product containing probiotic bacteria (six lactobacilli and 3 bifidobacteria). Effects of treatments on crying behavior will be assessed by using parental 24h paper diaries. Fecal calprotectin values at the beginning and at the end of the study will be evaluated using BÜHLMANN Quantum Blue® Calprotectin High Range (Schönenbuch, Switzerland), a quantitative immunoassay.
- Conditions
- Infantile Colic
- Being tested
- Simethicone Solution, Multilac Baby
- Medical subject headings
- Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simethicone SolutionDrug
Also called Control Group
Oral daily treatment for four weeks
Multilac BabyDietary supplement
Also called Treatment Group
Oral daily treatment for four weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Multilac Baby |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1-30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study startDec 2020 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Infantile ColicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hanna Krauss, Prof., Principal investigator, The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04666324
- Sponsor's protocol ID
- Kalisz 2020-02
- Status last verified
- Dec 2020
- First submitted
- 7 Dec 2020
- Last updated
- 14 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32403297Sommermeyer 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.
PubMed 36245729Bernatek 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.
PubMed 35208884
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Simethicone and Multilac Baby on Fecal Calprotectin Levels Infantile Colic
- ClinicalTrials.gov ID
- NCT04666324
- Acronym / sponsor ID
- Kalisz 2020-02
- Conditions
- Infantile Colic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The President Stanisław Wojciechowski State University of Applied Sciences in KaliszUniversity, hospital or other
- Study start
- Dec 2020 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 14 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Babies aged 3 to 6 weeks will be diagnosed for infantile colic using the Wessel's criteria. Study design will be open label with two parallel arms (Simethicone and Multilac Baby). Multilac Baby is a synbiotic product containing probiotic bacteria (six lactobacilli and 3 bifidobacteria). Effects of treatments on crying behavior will be assessed by using parental 24h paper diaries. Fecal calprotectin values at the beginning and at the end of the study will be evaluated using BÜHLMANN Quantum Blue® Calprotectin High Range (Schönenbuch, Switzerland), a quantitative immunoassay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simethicone Solution | Active comparator | Drug: Simethicone SolutionTreatment 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. |
| Multilac Baby | Experimental | Dietary Supplement: Multilac BabyTreatment 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. |
Who may qualify
- Ages
- 3 to 6 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- diagnosed for infantile colic according to Wessel's criteria
Key exclusion criteria (2 listed)
- previous treatment with probiotic or synbiotic
- previous treatment with antibiotics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simethicone SolutionAlso: Control GroupOral daily treatment for four weeks | Drug | Simethicone Solution |
| Multilac BabyAlso: Treatment GroupOral daily treatment for four weeks | Dietary supplement | Multilac Baby |
Primary outcome
Change of days of crying
Time frame: Three weeks
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.
Change of average duration of evening crying
Time frame: Three weeks
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.
Change of fecal calprotectin values
Time frame: 1-30 days
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2020.
- Results publication: PubMed 32403297Piatek 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.
- Derived from this study: PubMed 36245729Sommermeyer 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.
- Derived from this study: PubMed 35208884Bernatek 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.
- PublicationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacek Piatek, Prof. contact
Hanna Krauss, Prof. principal investigator
The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simethicone Solution and Multilac Baby in people with Infantile Colic, run by The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanna i Krauss, Prof. (+48 88 33 89 ext. 788, hjk12@pczta.fm), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of days of crying (time frame: Three weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04666324, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2020.