Infantile ColicPhase 2NCT04487834

Effects of Vivatlac Baby on Crying Behavior of Colicky Babies

A Phase 2 study testing Simethicone Solution and Vivatlac Baby in people with Infantile Colic, run by The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz at 2 sites in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Open trial with two parallel arms, assessing the effects of Simethicone and Vivatlac Baby 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 Vivatlac Baby
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 87 participants
Where: 2 sitesPoland
Study dates: 16 Apr 2020to 30 Jun 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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.

Poland2 sites

GP Practice Pro Familia
Koziegłowy, 62028
Medical University in Poznań
Poznan, 61701

Other trials in Poland

About this study

Official title: Effects of Simethicone and Vivatlac Baby in Infantile Colic

Open trial with two parallel arms, assessing the effects of Simethicone and Vivatlac Baby 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 Vivatlac Baby). Vivatlac 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.

Conditions: Infantile Colic
Being tested: Simethicone Solution, Vivatlac 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 Simethicone
Oral daily treatment for four weeks
Vivatlac BabyDietary supplement
Also called Multistrain Synbiotic
Oral daily treatment for four weeks

Study groups in NCT04487834
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
Vivatlac Baby	Experimental	Treatment with one stick pack of the multi-strain synbiotic (Vivatlac® Baby, Vivatrex GmbH, Rees, Germany) per day for four weeks. Each stick pack of Vivatlac® 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: Vivatlac Baby

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With a Reduction of Days Crying Equal or More Than 50 Percent From Baseline
Measurement of days of crying during last three weeks before enrollment and before the end of treatment. Treatment success was determined by calculation the percentage of patients for whom the measurement was reduced by the respective treatment by equal or more than 50 percent, compared to the value at the time of enrollment.
Measured: Three weeks
Number of Participants With a Reduction of Average Duration of Evening Crying Equal or More Than 50 Percent
Measurement of average duration of evening crying during last three weeks before enrollment and before the end of treatment. Treatment success was determined by calculation the percentage of patients for whom the measurement was reduced by the respective treatment by equal or more than 50 percent, compared to the value at the time of enrollment.
Measured: Three weeks
Number of Participants With a Reduction of Average Number of Crying Phases Per Day Equal or More Than 50 Percent
Measurement average number of crying phases per day during last three weeks before enrollment and before the end of treatment. Treatment success was determined by calculation the percentage of patients for whom the measurement was reduced by the respective treatment by equal or more than 50 percent, compared to the value at the time of enrollment.
Measured: Three weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Apr 202030 Jun 2020

First posted27 Jul 2020
Study start16 Apr 2020
Primary completion30 Jun 2020
Study completion30 Jun 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 87 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04487834
Sponsor's protocol ID: Kalisz 2020-01
Status last verified: Nov 2023
First submitted: 22 Jul 2020
Last updated: 22 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
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 32403297
Piatek J, Bernatek M, Krauss H, Wojciechowska M, Checinska-Maciejewska Z, Kaczmarek P, Sommermeyer H. Effects of a nine-strain bacterial synbiotic compared to simethicone in colicky babies - an open-label randomised study. Benef Microbes. 2021 Jun 15;12(3):249-257. doi: 10.3920/BM2020.0160. Epub 2021 Mar 26.
PubMed 33765904

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Comparative Efficacy of IV Dexamethasone vs. Nebulized Terbutaline for Renal Colic Pain in the ED
Renal Colic
Recruiting
The Effect of Probiotics in Infantile Colic
Infantile Colic
Active, not recruiting
Evaluating the Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With Colic
Infantile Colic
Recruiting
Contribution of Preserving the Superior Left Colic Artery to the Vascularization of the Descending Colon Prior to Colorectal Anastomosis During Left-Sided or Rectal Resections for Colorectal or Ovarian Cancer. (Revascularisation Colique)
Rectal Cancer, Colon Cancer
Active, not recruiting
RELIEF-pathway in Patients With Upper Abdominal Pain
Abdominal Pain, Gallstone; Colic

All Infantile Colic trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Simethicone and Vivatlac Baby in Infantile Colic
ClinicalTrials.gov ID: NCT04487834
Acronym / sponsor ID: Kalisz 2020-01
Conditions: Infantile Colic
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 87 participants (actual)
Lead sponsor: The President Stanisław Wojciechowski State University of Applied Sciences in KaliszUniversity, hospital or other
Study start: 16 Apr 2020 (actual)
Primary completion: 30 Jun 2020 (actual)
Study completion: 30 Jun 2020 (actual)
First posted: 27 Jul 2020 (actual)
Results: Posted 22 Nov 2023

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 Vivatlac Baby in babies diagnosed for infantile colic.

Detailed description

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.
Vivatlac Baby	Experimental	Dietary Supplement: Vivatlac BabyTreatment with one stick pack of the multi-strain synbiotic (Vivatlac® Baby, Vivatrex GmbH, Rees, Germany) per day for four weeks. Each stick pack of Vivatlac® 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: SimethiconeOral daily treatment for four weeks	Drug	Simethicone Solution
Vivatlac BabyAlso: Multistrain SynbioticOral daily treatment for four weeks	Dietary supplement	Vivatlac Baby

Primary outcome

Number of Participants With a Reduction of Days Crying Equal or More Than 50 Percent From Baseline
Time frame: Three weeks
Measurement of days of crying during last three weeks before enrollment and before the end of treatment. Treatment success was determined by calculation the percentage of patients for whom the measurement was reduced by the respective treatment by equal or more than 50 percent, compared to the value at the time of enrollment.
Number of Participants With a Reduction of Average Duration of Evening Crying Equal or More Than 50 Percent
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 was determined by calculation the percentage of patients for whom the measurement was reduced by the respective treatment by equal or more than 50 percent, compared to the value at the time of enrollment.
Number of Participants With a Reduction of Average Number of Crying Phases Per Day Equal or More Than 50 Percent
Time frame: Three weeks
Measurement average number of crying phases per day during last three weeks before enrollment and before the end of treatment. Treatment success was determined by calculation the percentage of patients for whom the measurement was 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 posted to the registry on 22 Nov 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Simethicone Solution	33	33
Multilac Baby	54	54

Primary outcome: Number of Participants With a Reduction of Days Crying Equal or More Than 50 Percent From Baseline

Time frame: Three weeks. Count of participants. Unit: Participants

Measure	Simethicone Solution n = 33	Vivatlac Baby n = 54
Value	6	39

Simethicone Solution vs Vivatlac Baby: p <0.0001, Fisher Exact

Primary outcome: Number of Participants With a Reduction of Average Duration of Evening Crying Equal or More Than 50 Percent

Time frame: Three weeks. Count of participants. Unit: Participants

Measure	Simethicone Solution n = 33	Vivatlac Baby n = 54
Value	13	46

Simethicone Solution vs Vivatlac Baby: p = 0.0001, Fisher Exact

Primary outcome: Number of Participants With a Reduction of Average Number of Crying Phases Per Day Equal or More Than 50 Percent

Time frame: Three weeks. Count of participants. Unit: Participants

Measure	Simethicone Solution n = 33	Vivatlac Baby n = 54
Value	14	27

Simethicone Solution vs Vivatlac Baby: p = 0.4852, Fisher Exact

Adverse events

Time frame: 4 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Simethicone Solution	0 of 33 (0%)	0 of 33 (0%)	0 of 33
Multilac Baby	0 of 54 (0%)	0 of 54 (0%)	0 of 54

Limitations and caveats (from the sponsor): A limitation of the study is the use of parental diaries to measure infants' crying behavior. Using paper diaries is not without problems. Nevertheless, it has been shown that paper diary recordings of common infant behavior can provide reasonably good estimates of durations, while behavioral frequencies may be underestimated. Another major limitation of the study is that medication was not blinded.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: 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 33765904Piatek J, Bernatek M, Krauss H, Wojciechowska M, Checinska-Maciejewska Z, Kaczmarek P, Sommermeyer H. Effects of a nine-strain bacterial synbiotic compared to simethicone in colicky babies - an open-label randomised study. Benef Microbes. 2021 Jun 15;12(3):249-257. doi: 10.3920/BM2020.0160. Epub 2021 Mar 26.
In-Vitro Growth Inhibition of Bacterial Pathogens by Probiotics and a Synbiotic: Product Composition MattersLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Infantile Colic

RecruitingPhase 3
Comparative Efficacy of IV Dexamethasone vs. Nebulized Terbutaline for Renal Colic Pain in the ED
Renal Colic
Recruiting
The Effect of Probiotics in Infantile Colic
Infantile Colic
Active, not recruiting
Evaluating the Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With Colic
Infantile Colic
Recruiting
Contribution of Preserving the Superior Left Colic Artery to the Vascularization of the Descending Colon Prior to Colorectal Anastomosis During Left-Sided or Rectal Resections for Colorectal or Ovarian Cancer. (Revascularisation Colique)
Rectal Cancer, Colon Cancer
Active, not recruiting
RELIEF-pathway in Patients With Upper Abdominal Pain
Abdominal Pain, Gallstone; Colic

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.

Hanna Krauss, Prof. principal investigator

University of Applied Sciences in Kalisz, Poland

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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: finished, as of the sponsor's last update on 22 Nov 2023. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With a Reduction of Days Crying Equal or More Than 50 Percent From Baseline (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 NCT04487834, which also lists 2 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 22 Nov 2023.