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This is a single-center, randomized, double blind controlled study to investigate the effects of Bifidobacterium, BB-12® versus placebo in a study group of pediatric patients with infantile colic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Experimental | patients who take Bifidobacterium BB-12® (Bifidolactis Infant), 6 drops a day (guaranteeing a billion of living cells) for 28 consecutive days; |
|
| Group II | Placebo Comparator | patients who take Bifidolactis Infant Placebo 6 drops a day for 28 consecutive days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bifidobacterium, BB-12® (Bifidolactis Infant) | Dietary Supplement |
| ||
| Bifidolactis Infant Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With >=50% Reduction in Mean Weekly Crying Duration | Treatment success rate was evaluated in terms of reduction of crying duration, comparing mean weekly duration of the last Week (from T4 to T5) and mean weekly duration of Week 1 (from T0 to T1). The daily number and duration of crying episodes has been collected in the 'Evaluation of crying' section of the patient diary. Weekly mean is defined as the mean of the calculated average daily durations during the selected week and is described by means of descriptive statistics for continuous data. Mean changes from baseline (i.e. mean of the first Week) to the mean of the selected week will be computed as well. The following categories of patients has been defined: Success = patients who meet the criteria for the treatment success rate No Success = patients who do not meet the criteria for the treatment success rate Missing = patients who did not do the last visit (Visit T5 - at 28 days from baseline) | at 28 days from the baseline (Visit T5) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Crying Episodes | Weekly mean of cries will be defined as the mean number of cries reported in the "Evaluation of behavior" section during the week (i.e. number of episodes/number of days with episodes) and will be described by means of descriptive statistics for continuous data. Mean changes from baseline (i.e. mean of the first Week) to the mean of the selected week will be analyzed too. |
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Inclusion Criteria:
Patients are included in the study if they meet all the following criteria:
Exclusion Criteria:
Patients are excluded from this study if they meet any of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roberto Berni Canani, Prof. | Federico II University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dipartimento di Scienze Mediche Traslazionali - Sezione Pediatria - Università degli Studi di napoli "Federico II" | Naples | 80131 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16678565 | Background | Hyman PE, Milla PJ, Benninga MA, Davidson GP, Fleisher DF, Taminiau J. Childhood functional gastrointestinal disorders: neonate/toddler. Gastroenterology. 2006 Apr;130(5):1519-26. doi: 10.1053/j.gastro.2005.11.065. | |
| 22981952 | Background | Szajewska H, Gyrczuk E, Horvath A. Lactobacillus reuteri DSM 17938 for the management of infantile colic in breastfed infants: a randomized, double-blind, placebo-controlled trial. J Pediatr. 2013 Feb;162(2):257-62. doi: 10.1016/j.jpeds.2012.08.004. Epub 2012 Sep 14. |
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The study was a randomized, double-blind, placebo-controlled parallel-group study. Eighty (80) infants were screened and all were enrolled in the study and randomized (40 to Bifidobacteriium BB-12® and 40 to Placebo).
The enrollment period started on 11-Nov-2016 and closed on 6-Nov-2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bifidobacterium BB-12® | patients who take Bifidobacterium BB-12® (Bifidolactis Infant), 6 drops a day (guaranteeing a billion of living cells) for 28 consecutive days. |
| FG001 | Placebo | patients who take Bifidolactis Infant Placebo 6 drops a day for 28 consecutive days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bifidobacterium BB-12® | patients who take Bifidobacterium BB-12® (Bifidolactis Infant), 6 drops a day (guaranteeing a billion of living cells) for 28 consecutive days; Bifidobacterium, BB-12® (Bifidolactis Infant) |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With >=50% Reduction in Mean Weekly Crying Duration | Treatment success rate was evaluated in terms of reduction of crying duration, comparing mean weekly duration of the last Week (from T4 to T5) and mean weekly duration of Week 1 (from T0 to T1). The daily number and duration of crying episodes has been collected in the 'Evaluation of crying' section of the patient diary. Weekly mean is defined as the mean of the calculated average daily durations during the selected week and is described by means of descriptive statistics for continuous data. Mean changes from baseline (i.e. mean of the first Week) to the mean of the selected week will be computed as well. The following categories of patients has been defined: Success = patients who meet the criteria for the treatment success rate No Success = patients who do not meet the criteria for the treatment success rate Missing = patients who did not do the last visit (Visit T5 - at 28 days from baseline) | Intention to Treat Set (ITT): all randomized patients who received at least one dose of study treatment. Following the intent-to-treat (ITT) principle, patients were analyzed according to the treatment they were assigned to at the randomization visit. Patients drop-out were also considered and classified as Treatment success rate = "Missing". | Posted | Count of Participants | Participants | at 28 days from the baseline (Visit T5) |
5 weeks starting from the patient enrollment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bifidobacterium BB-12® | patients who take Bifidobacterium BB-12® (Bifidolactis Infant), 6 drops a day (guaranteeing a billion of living cells) for 28 consecutive days; Bifidobacterium, BB-12® (Bifidolactis Infant) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| LAURA PATRUCCO | SOFAR S.p.A | +390202 909 362291 | laura.patrucco@sofarfarm.it |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 16, 2018 | Dec 4, 2019 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Dec 4, 2019 | Dec 4, 2019 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D003085 | Colic |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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This is a prospective randomized double blind placebo controlled clinical trial
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| Dietary Supplement |
|
| at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5) |
| Infectious Diseases Incidence | Number of infections in respiratory system, gastrointestinal system, urinary tract and skin. An infection was defined as an Adverse Event with SOC equal to "Infections and Infestations". | at each visit, for 5 weeks starting from the enrollment in the study (Visit T0, T1, T2, T3, T4 and T5) |
| Bowel Evacuation - Stool Frequency | Daily frequency of bowel evacuation. The frequency of stools were collected daily in the diary. Stool frequency was evaluated as the mean of total daily stools reported per week. | at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5) |
| Bowel Evacuation - Stool Consistency | Stool consistency was evaluated as the number and the proportion of patients who reported at least one stool sample of each type per week, according to Bristol scale as follows: Type A = separate hard lumps, like nuts (hard to pass) Type B = sausage-shaped, but lumpy Type C = Like a sausage but with cracks on its surface Type D = like a sausage or snake, smooth and soft Only a descriptive statistics Type E = soft blobs with clear-cut edges (passed easily) Type F = fluffy pieces with ragged edges, a mushy stool Type G = watery, no solid pieces (entirely liquid). Patients could report more than one stool consistency per day then the sum of the "Count of Participants" for each group at each visit could be Greater then the "Overall Number of Participants Analyzed" | at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5) |
| Infant's Mood | The infant's mood (calm, asleep, agitated, irritable) was collected daily in the diary and was evaluated as the number and the proportion of infants who reported at least one mood of each type per week. Patients could report more than one mood per day then the sum of the "Count of Participants" for each group at each visit could be greater then the "Overall Number of Participants Analyzed". | at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5) |
| Infant's Sleep | Duration of sleep (in minutes) was collected daily in the diary during the entire study period. Mean daily duration of sleep by week was defined as the mean of the daily durations during the selected week and was described by means of descriptive statistics for continuous data. | at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5) |
| Infant's Temper | Duration of temper episodes (in minutes) was collected daily in the diary during the entire study period. Mean daily duration of temper episodes by week was defined as the mean of the daily durations during the selected week and was described by means of descriptive statistics for continuous data. | at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5) |
| Infant's Feeding | Duration of feeding (in minutes) was collected daily in the diary during the entire study period. Mean daily feeding time by week was defined as the mean of the daily durations during the selected week and was described by means of descriptive statistics for continuous data. | at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5) |
| Calprotectin | Evaluation of calprotectin levels in fecal samples | at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5) |
| Beta-defensin Type 2 | Evaluation of Beta-defensin type 2 levels in fecal samples | at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5) |
| LL37 Peptide | Evaluation of LL37 peptide levels in fecal samples | at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5) |
| Short Chain Fatty Acids - Butyrate | Evaluation of Butyrate levels in fecal samples | at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5) |
| Secretory Immunoglobulin A (SIgA) | Secretory immunoglobulin A (SIgA) levels in fecal samples | at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5) |
| 22196482 | Background | Kabeerdoss J, Devi RS, Mary RR, Prabhavathi D, Vidya R, Mechenro J, Mahendri NV, Pugazhendhi S, Ramakrishna BS. Effect of yoghurt containing Bifidobacterium lactis Bb12(R) on faecal excretion of secretory immunoglobulin A and human beta-defensin 2 in healthy adult volunteers. Nutr J. 2011 Dec 23;10:138. doi: 10.1186/1475-2891-10-138. |
| 18552710 | Background | Mohan R, Koebnick C, Schildt J, Mueller M, Radke M, Blaut M. Effects of Bifidobacterium lactis Bb12 supplementation on body weight, fecal pH, acetate, lactate, calprotectin, and IgA in preterm infants. Pediatr Res. 2008 Oct;64(4):418-22. doi: 10.1203/PDR.0b013e318181b7fa. |
| 16971641 | Background | Mohan R, Koebnick C, Schildt J, Schmidt S, Mueller M, Possner M, Radke M, Blaut M. Effects of Bifidobacterium lactis Bb12 supplementation on intestinal microbiota of preterm infants: a double-blind, placebo-controlled, randomized study. J Clin Microbiol. 2006 Nov;44(11):4025-31. doi: 10.1128/JCM.00767-06. Epub 2006 Sep 13. |
| 19604166 | Background | Savino F, Cordisco L, Tarasco V, Calabrese R, Palumeri E, Matteuzzi D. Molecular identification of coliform bacteria from colicky breastfed infants. Acta Paediatr. 2009 Oct;98(10):1582-8. doi: 10.1111/j.1651-2227.2009.01419.x. Epub 2009 Jul 9. |
| 21470331 | Background | Hall B, Chesters J, Robinson A. Infantile colic: a systematic review of medical and conventional therapies. J Paediatr Child Health. 2012 Feb;48(2):128-37. doi: 10.1111/j.1440-1754.2011.02061.x. Epub 2011 Apr 7. |
| 15693915 | Background | Savino F, Bailo E, Oggero R, Tullio V, Roana J, Carlone N, Cuffini AM, Silvestro L. Bacterial counts of intestinal Lactobacillus species in infants with colic. Pediatr Allergy Immunol. 2005 Feb;16(1):72-5. doi: 10.1111/j.1399-3038.2005.00207.x. |
| 15244234 | Background | Savino F, Cresi F, Pautasso S, Palumeri E, Tullio V, Roana J, Silvestro L, Oggero R. Intestinal microflora in breastfed colicky and non-colicky infants. Acta Paediatr. 2004 Jun;93(6):825-9. |
| 12352253 | Background | Gupta SK. Is colic a gastrointestinal disorder? Curr Opin Pediatr. 2002 Oct;14(5):588-92. doi: 10.1097/00008480-200210000-00005. |
| 11316682 | Background | Lucassen PL, Assendelft WJ, van Eijk JT, Gubbels JW, Douwes AC, van Geldrop WJ. Systematic review of the occurrence of infantile colic in the community. Arch Dis Child. 2001 May;84(5):398-403. doi: 10.1136/adc.84.5.398. |
| 13872677 | Background | BRAZELTON TB. Crying in infancy. Pediatrics. 1962 Apr;29:579-88. No abstract available. |
| 21710185 | Background | Iacovou M, Ralston RA, Muir J, Walker KZ, Truby H. Dietary management of infantile colic: a systematic review. Matern Child Health J. 2012 Aug;16(6):1319-31. doi: 10.1007/s10995-011-0842-5. |
| Non-compliance of family |
|
| Difficulties in completing daily diary |
|
patients who take Bifidolactis Infant Placebo 6 drops a day for 28 consecutive days.
Bifidolactis Infant Placebo
| BG002 | Total | Total of all reporting groups |
| days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Type of childbirth | Count of Participants | Participants |
|
| Gestational age | Mean | Standard Deviation | weeks |
|
| Birth weight | Mean | Standard Deviation | grams |
|
| Apgar 5 minutes score | The Apgar score (APGAR is the acronym of Appearance, Pulse, Grimace, Activity, Respiration) is a method used to summarize the health of newborn children. It evaluates five parameters (Skin colors, Pulse rate, Reflex irritability grimace, Muscle tone, Respiratory effort) assigning to each parameter a score from 0 to 2 (values 0, 1, 2) and summing up the five values. The resulting score ranges from 0 to 10. APGAR 5 minutes means that the test is done at 5 minutes after birth. Scores > 7 are considered normal; 4 to 6, fairly low; and < 3 are generally regarded as critically low. | Mean | Standard Deviation | scores on a scale |
|
| Positive family history of allergic disease | Count of Participants | Participants |
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| Positive family history of functional gastrointestinal diseases | Count of Participants | Participants |
|
| Clinical/surgical history | Count of Participants | Participants |
|
| Exposure to second-hand tobacco smoke within the home environment | Count of Participants | Participants |
|
| Smoking habits | Count of Participants | Participants |
|
|
|
|
|
| Secondary | Number of Crying Episodes | Weekly mean of cries will be defined as the mean number of cries reported in the "Evaluation of behavior" section during the week (i.e. number of episodes/number of days with episodes) and will be described by means of descriptive statistics for continuous data. Mean changes from baseline (i.e. mean of the first Week) to the mean of the selected week will be analyzed too. | Intention to Treat Set (ITT): all randomized patients who received at least one dose of study treatment. The number of participants analyzed in Visit T5 is less then Visit T1 since 8 participants dropped from the study before Visit T5 | Posted | Mean | Standard Deviation | number of episodes | at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5) |
|
|
|
|
| Secondary | Infectious Diseases Incidence | Number of infections in respiratory system, gastrointestinal system, urinary tract and skin. An infection was defined as an Adverse Event with SOC equal to "Infections and Infestations". | Intention to Treat Set (ITT): all randomized patients who received at least one dose of study treatment. | Posted | Mean | Standard Deviation | Number of infections | at each visit, for 5 weeks starting from the enrollment in the study (Visit T0, T1, T2, T3, T4 and T5) |
|
|
|
| Secondary | Bowel Evacuation - Stool Frequency | Daily frequency of bowel evacuation. The frequency of stools were collected daily in the diary. Stool frequency was evaluated as the mean of total daily stools reported per week. | Intention to Treat Set (ITT): all randomized patients who received at least one dose of study treatment. The number of participants analyzed in Visit T5 is less then Visit T1 since 8 participants dropped from the study before Visit T5 | Posted | Mean | Standard Deviation | daily number of bowel evacuations | at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5) |
|
|
|
|
| Secondary | Bowel Evacuation - Stool Consistency | Stool consistency was evaluated as the number and the proportion of patients who reported at least one stool sample of each type per week, according to Bristol scale as follows: Type A = separate hard lumps, like nuts (hard to pass) Type B = sausage-shaped, but lumpy Type C = Like a sausage but with cracks on its surface Type D = like a sausage or snake, smooth and soft Only a descriptive statistics Type E = soft blobs with clear-cut edges (passed easily) Type F = fluffy pieces with ragged edges, a mushy stool Type G = watery, no solid pieces (entirely liquid). Patients could report more than one stool consistency per day then the sum of the "Count of Participants" for each group at each visit could be Greater then the "Overall Number of Participants Analyzed" | Intention to Treat Set (ITT): all randomized patients who received at least one dose of study treatment. The number of participants analyzed in Visit T5 is less then Visit T1 since 8 participants dropped from the study before Visit T5. | Posted | Number | participants | at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5) |
|
|
|
| Secondary | Infant's Mood | The infant's mood (calm, asleep, agitated, irritable) was collected daily in the diary and was evaluated as the number and the proportion of infants who reported at least one mood of each type per week. Patients could report more than one mood per day then the sum of the "Count of Participants" for each group at each visit could be greater then the "Overall Number of Participants Analyzed". | Intention to Treat Set (ITT): all randomized patients who received at least one dose of study treatment. The number of participants analyzed in Visit T5 is less then Visit T1 since 8 participants dropped from the study before Visit T5 | Posted | Number | participants | at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5) |
|
|
|
| Secondary | Infant's Sleep | Duration of sleep (in minutes) was collected daily in the diary during the entire study period. Mean daily duration of sleep by week was defined as the mean of the daily durations during the selected week and was described by means of descriptive statistics for continuous data. | Intention to Treat Set (ITT): all randomized patients who received at least one dose of study treatment. The number of participants analyzed in Visit T5 is less then Visit T1 since 8 participants dropped from the study before Visit T5 | Posted | Mean | Standard Deviation | minutes | at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5) |
|
|
|
| Secondary | Infant's Temper | Duration of temper episodes (in minutes) was collected daily in the diary during the entire study period. Mean daily duration of temper episodes by week was defined as the mean of the daily durations during the selected week and was described by means of descriptive statistics for continuous data. | Intention to Treat Set (ITT): all randomized patients who received at least one dose of study treatment. | Posted | Mean | Standard Deviation | minutes | at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5) |
|
|
|
| Secondary | Infant's Feeding | Duration of feeding (in minutes) was collected daily in the diary during the entire study period. Mean daily feeding time by week was defined as the mean of the daily durations during the selected week and was described by means of descriptive statistics for continuous data. | Intention to Treat Set (ITT): all randomized patients who received at least one dose of study treatment. | Posted | Mean | Standard Deviation | minutes | at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5) |
|
|
|
| Secondary | Calprotectin | Evaluation of calprotectin levels in fecal samples | The analysis Population includes all participants for wich an evaluable fecal sample was available at Visit T1 and Visit T5 | Posted | Mean | Standard Deviation | mM/Kg | at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5) |
|
|
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| Secondary | Beta-defensin Type 2 | Evaluation of Beta-defensin type 2 levels in fecal samples | The analysis Population includes all participants for wich an evaluable fecal sample was available at Visit T1 and Visit T5 | Posted | Mean | Standard Deviation | ng/g | at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5) |
|
|
|
| Secondary | LL37 Peptide | Evaluation of LL37 peptide levels in fecal samples | The analysis Population includes all participants for wich an evaluable fecal sample was available at Visit T1 and Visit T5 | Posted | Mean | Standard Deviation | ng/g | at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5) |
|
|
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| Secondary | Short Chain Fatty Acids - Butyrate | Evaluation of Butyrate levels in fecal samples | The analysis Population includes all participants for wich an evaluable fecal sample was available at Visit T1 and Visit T5 | Posted | Mean | Standard Deviation | mM/Kg | at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5) |
|
|
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| Secondary | Secretory Immunoglobulin A (SIgA) | Secretory immunoglobulin A (SIgA) levels in fecal samples | The analysis Population includes all the participants for wich an evaluable fecal sample was available at Visit T1 and Visit T5 | Posted | Mean | Standard Deviation | microg/g | at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5) |
|
|
|
| 0 |
| 40 |
| 1 |
| 40 |
| 0 |
| 40 |
| EG001 | Placebo | patients who take Bifidolactis Infant Placebo 6 drops a day for 28 consecutive days. Bifidolactis Infant Placebo | 0 | 40 | 0 | 40 | 0 | 40 |
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| Father |
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| No one |
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| Visit T5 |
|
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| Visit T2 |
|
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| Visit T3 |
|
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| Visit T4 |
|
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| Visit T5 |
|
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| T1: Patients with at least one stool of type E |
|
| T1: Patients with at least one stool of type F |
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| T1: Patients with at least one stool of type G |
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| T2: Patients with at least one stool of type C |
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| T2: Patients with at least one stool of type D |
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| T2: Patients with at least one stool of type E |
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| T2: Patients with at least one stool of type F |
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| T2: Patients with at least one stool of type G |
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| T3: Patients with at least one stool of type C |
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| T3: Patients with at least one stool of type D |
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| T3: Patients with at least one stool of type E |
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| T3: Patients with at least one stool of type F |
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| T3: Patients with at least one stool of type G |
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| T4: Patients with at least one stool of type C |
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| T4: Patients with at least one stool of type D |
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| T4: Patients with at least one stool of type E |
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| T4: Patients with at least one stool of type F |
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| T4: Patients with at least one stool of type G |
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| T5: Patients with at least one stool of type C |
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| T5: Patients with at least one stool of type D |
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| T5: Patients with at least one stool of type E |
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| T5: Patients with at least one stool of type F |
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| T5: Patients with at least one stool of type G |
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| T1: Pts. with at least one mood equal to Asleep |
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| T1: Pts. with at least one mood equal to Agitated |
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| T1: Pts. with at least one mood equal to Irritable |
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| T2: Pts. with at least one mood equal to Calm |
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| T2: Pts. with at least one mood equal to Asleep |
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| T2: Pts. with at least one mood equal to Agitated |
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| T2: Pts. with at least one mood equal to Irritable |
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| T3: Pts. with at least one mood equal to Calm |
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| T3: Pts. with at least one mood equal to Asleep |
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| T3: Pts. with at least one mood equal to Agitated |
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| T3: Pts. with at least one mood equal to Irritable |
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| T4: Pts. with at least one mood equal to Calm |
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| T4: Pts. with at least one mood equal to Asleep |
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| T4: Pts. with at least one mood equal to Agitated |
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| T4: Pts. with at least one mood equal to Irritable |
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| T5: Pts. with at least one mood equal to Calm |
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| T5: Pts. with at least one mood equal to Asleep |
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| T5: Pts. with at least one mood equal to Agitated |
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| T5: Pts. with at least one mood equal to Irritable |
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| Visit T2 |
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| Visit T3 |
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| Visit T4 |
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| Visit T5 |
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| Visit T2 |
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| Visit T3 |
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| Visit T4 |
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| Visit T5 |
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| Visit T2 |
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| Visit T3 |
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| Visit T4 |
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| Visit T5 |
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