Functional Gastrointestinal DisordersNCT04944628
Observational Prospective Study With Probiotic Supplementation on Infants With FGDI
An observational study of Functional Gastrointestinal Disorders and Infantile Colic, run by AB Biotics, SA at 1 site in Italy.
Trial summary
This observational prospective study evaluates the safety, tolerability and efficacy of a probiotic formula in infants with functional gastrointestinal disorders (FGDI) Read more about this study
- Who is it for?
- Ages 1 month to 10 months
- Conditions the study is for
- Functional Gastrointestinal Disorders, Infantile Colic, Functional Constipation
- What is being tested?
- Probiotic
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 15 Aug 2018to 5 Dec 2018
- Phase
- Observational
- 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 1 month to 10 months
- All sexes
- No healthy volunteers
- Child
Study population: Population selected from primary care clinic.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
This observational prospective study evaluates the safety, tolerability and efficacy of a probiotic formula in infants with functional gastrointestinal disorders (FGDI)
Read the detailed 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.
- Being tested
- Probiotic
- Keywords
- FGDI, probiotic
- Medical subject headings
- Gastrointestinal Diseases, Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Probiotic in liquid format (oil suspension) administered 10 drops once daily for 2 weeks (2x10^9 cfu/day)
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day 1 and day 14
Secondary outcomes (5)
Change in excessive crying severity
Excessive crying score measured using 5-point Likert scales (0: no symptoms, to 4: extremely severe symptoms)
Measured: Day 1 and day 14
Change in constipation severity
Constipation score measured using 5-point Likert scales (0: no symptoms, to 4: extremely severe symptoms)
Measured: Day 1 and day 14
Change in parental anxiety
Recorded through the validated Generalized Anxiety Disorder (GAD) 7-item scale (GAD-7).
Measured: Day 1 and day 14
Tolerability and safety
Any adverse events experienced throughout study period
Measured: Daily from day 1 to day 14
Parental satisfaction with the product
Measured with a 5-point Likert scale (0: very dissatisfied, to 4: very satisfied)
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start15 Aug 2018
- Primary completion5 Dec 2018
- Study completion5 Dec 2018
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 Functional Gastrointestinal DisordersStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- AB Biotics, SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maura Sticco, MD, Principal investigator, Azienda Sanitaria Locale Napoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04944628
- Sponsor's protocol ID
- Normocolic ADL
- Status last verified
- Jun 2021
- First submitted
- 14 Jun 2021
- Last updated
- 29 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171Benninga MA, Faure C, Hyman PE, St James Roberts I, Schechter NL, Nurko S. Childhood Functional Gastrointestinal Disorders: Neonate/Toddler. Gastroenterology. 2016 Feb 15:S0016-5085(16)00182-7. doi: 10.1053/j.gastro.2016.02.016. Online ahead of print.
PubMed 27144631Asto E, Huedo P, Altadill T, Aguilo Garcia M, Sticco M, Perez M, Espadaler-Mazo J. Probiotic Properties of Bifidobacterium longum KABP042 and Pediococcus pentosaceus KABP041 Show Potential to Counteract Functional Gastrointestinal Disorders in an Observational Pilot Trial in Infants. Front Microbiol. 2022 Jan 12;12:741391. doi: 10.3389/fmicb.2021.741391. eCollection 2021.
PubMed 35095783
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04944628
- Acronym / sponsor ID
- Normocolic ADL
- Keywords
- FGDI, probiotic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- AB Biotics, SAIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 5 Dec 2018 (actual)
- Study completion
- 5 Dec 2018 (actual)
- First posted
- 29 Jun 2021 (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.
This observational prospective study evaluates the safety, tolerability and efficacy of a probiotic formula in infants with functional gastrointestinal disorders (FGDI)
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 10 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Population selected from primary care clinic.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| ProbioticProbiotic in liquid format (oil suspension) administered 10 drops once daily for 2 weeks (2x10^9 cfu/day) | Dietary supplement | – |
Primary outcome
Change in total FGDI severity
Time frame: Day 1 and day 14
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)
5 secondary outcomes
Change in excessive crying severity
Time frame: Day 1 and day 14
Change in constipation severity
Time frame: Day 1 and day 14
Change in parental anxiety
Time frame: Day 1 and day 14
Tolerability and safety
Time frame: Daily from day 1 to day 14
Parental satisfaction with the product
Time frame: Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
- Background: PubMed 16717171Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Background: PubMed 27144631Benninga MA, Faure C, Hyman PE, St James Roberts I, Schechter NL, Nurko S. Childhood Functional Gastrointestinal Disorders: Neonate/Toddler. Gastroenterology. 2016 Feb 15:S0016-5085(16)00182-7. doi: 10.1053/j.gastro.2016.02.016. Online ahead of print.
- Derived from this study: PubMed 35095783Asto E, Huedo P, Altadill T, Aguilo Garcia M, Sticco M, Perez M, Espadaler-Mazo J. Probiotic Properties of Bifidobacterium longum KABP042 and Pediococcus pentosaceus KABP041 Show Potential to Counteract Functional Gastrointestinal Disorders in an Observational Pilot Trial in Infants. Front Microbiol. 2022 Jan 12;12:741391. doi: 10.3389/fmicb.2021.741391. eCollection 2021.
- 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.
Maura Sticco, MD principal investigator
Azienda Sanitaria Locale Napoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Gastrointestinal Disorders and Infantile Colic, run by AB Biotics, SA at 1 site in Italy.
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 3 inclusion and 4 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 29 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in total FGDI severity (time frame: Day 1 and day 14). 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 NCT04944628, 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 29 Jun 2021.