Trial · NCT07882537
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Composition of faecal intestinal microbiota in terms of concentration of L. casei DG® | 28 days | Bacterial genome count for L. casei DG® at 28th day of treatment using Real Time PCR |
| Secondary | Indicators of dysbiosis of the intestinal microbiota (α-diversity and β-diversity) at 28, 56 and 84 days | Days 28, 56, and 84 after the start of study product administration | Alpha diversity was assessed using the Shannon index to evaluate microbial richness and diversity within stool samples. Beta diversity was assessed using Unweighted UniFrac distance matrices and principal coordinate analysis to evaluate differences in overall gut microbiota composition. Stool samples were analyzed using 16S rRNA-targeted metagenomic sequencing. Comparisons were performed between the Enterolactis Baby® and placebo groups and across study visits. |
| Secondary | Bacterial genome count for L. casei DG® at 56 and 84 days; | Days 56 and 84 after the start of study product administration | The concentration of L. casei DG® (Lactobacillus paracasei CNCM I-1572) in stool samples was measured using a strain-specific real-time polymerase chain reaction (PCR) method. Results were expressed as colony-forming units per milliliter (CFU/mL) and compared between the Enterolactis Baby® and placebo groups during the follow-up period. |
| Secondary | Number of Faecal Evacuations | Days 1, 10, 28, 56, and 84 | The total number of faecal evacuations recorded during the 24-hour period before each scheduled study visit was assessed by treatment group and assessment time point. |
| Secondary | Number of Faecal Evacuations by Amount Category on the Amsterdam Infant Stool Scale | Days 1, 10, 28, 56, and 84 | The amount of each faecal evacuation recorded during the 24-hour period before each scheduled study visit was classified using the Amsterdam Infant Stool Scale. Amount was classified using four categories ranging from 1 to 4. Results were summarized as the number of faecal evacuations in each category by treatment group and assessment time point. Higher categories do not necessarily indicate a better or worse outcome. |
| Secondary | Number of Faecal Evacuations by Colour Category on the Amsterdam Infant Stool Scale | Days 1, 10, 28, 56, and 84 | The colour of each faecal evacuation recorded during the 24-hour period before each scheduled study visit was classified using the Amsterdam Infant Stool Scale. Colour was classified using six categories ranging from I to VI. Results were summarized as the number of faecal evacuations in each category by treatment group and assessment time point. The categories are descriptive, and higher categories do not indicate a better or worse outcome. |
| Secondary | Number of Faecal Evacuations by Consistency Category on the Amsterdam Infant Stool Scale | Days 1, 10, 28, 56, and 84 | The consistency of each faecal evacuation recorded during the 24-hour period before each scheduled study visit was classified using the Amsterdam Infant Stool Scale. Consistency was classified using four principal categories ranging from A to D, with intermediate categories recorded where applicable. Results were summarized as the number of faecal evacuations in each category by treatment group and assessment time point. The categories are descriptive, and higher categories do not necessarily indicate a better or worse outcome. |
| Secondary | Change in the Overall Stool Volatile Metabolomic Profil | Days 28, 56, and 84 after the start of study product administration | The overall stool volatile metabolomic profile was assessed by gas chromatography-mass spectrometry with solid-phase microextraction. Detected volatile metabolites were evaluated collectively using multivariate analyses to assess differences in the overall metabolic profile between the Enterolactis Baby and placebo groups across assessment time points. |
| Secondary | Presence of Infantile Colic Based on Rome IV Criteria | Study Days 10, 28, 56, and 84 | The presence of infantile colic was assessed according to the Rome IV diagnostic criteria. The number and percentage of infants meeting the criteria for infantile colic were evaluated and compared between the Enterolactis Baby® and placebo groups. |
| Secondary | Evaluation of adverse events | From Day 1 through Day 84, with assessments on Days 1, 10, 28, 56, and 84 | Adverse events were monitored throughout the study. The number and percentage of infants experiencing at least one adverse event were assessed by treatment group. Adverse events were evaluated with respect to seriousness, severity, outcome, and relationship to the study product. |
| Secondary | Number of Participants by Fatty Acid Status in Faeces | Days 1, 10, 28, 56, and 84 | Stool samples underwent physicochemical examination to assess fatty acid status. Results were summarized by treatment group and assessment time point. |
| Secondary | Number of Participants by Soap Status in Faeces | Days 1, 10, 28, 56, and 84 | Stool samples underwent physicochemical examination to classify soaps as present, absent, not evaluated, or missing. Results were summarized as the number of participants in each category by treatment group and assessment time point. |
| Secondary | Stercobilinogen Status in Faeces | Days 1, 10, 28, 56, and 84 | Stool samples underwent physicochemical examination to assess stercobilinogen status at each scheduled assessment time point. |
| Secondary | Number of Participants by Meat and Vegetable Fibre Status in Faeces | Days 1, 10, 28, 56, and 84 | Stool samples underwent physicochemical examination to classify meat and vegetable fibres as present, absent, or missing. Results were summarized as the number of participants in each category by treatment group and assessment time point. |
| Secondary | Number of Participants by Mucus Status in Faeces | Days 1, 10, 28, 56, and 84 | Stool samples underwent physicochemical examination to classify mucus as present, absent, not evaluated, or missing. Results were summarized as the number of participants in each category by treatment group and assessment time point. |
| Secondary | Amide Status in Faeces | Days 1, 10, 28, 56, and 84 | Stool samples underwent physicochemical examination to assess amide status at each scheduled assessment time point. |
| Secondary | Number of Participants by Faecal pH Category | Days 1, 10, 28, 56, and 84 | Stool samples underwent physicochemical examination to classify faecal pH as acidic, neutral, basic, or missing. Results were summarized as the number of participants in each category by treatment group and assessment time point. The categories are descriptive, and their order does not indicate a better or worse outcome. |
| Secondary | Number of Participants by Neutral Fat Status in Faeces | Days 1, 10, 28, 56, and 84 | Stool samples underwent physicochemical examination to classify neutral fat as present, absent, or missing. Results were summarized as the number of participants in each category by treatment group and assessment time point. |
| Secondary | Mean Body Weight | Days 1, 10, 28, 56, and 84 | Body weight was measured in grams at each scheduled study visit. Results were summarized by treatment group and assessment time point. |
| Secondary | Mean Head Circumference | Days 1, 10, 28, 56, and 84 | Head circumference was measured in centimetres at each scheduled study visit. Results were summarized by treatment group and assessment time point. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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