Food Supplement Physiomanna® Baby in Pediatric Patients

Study Overview
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Brief Summary
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The primary objective is to assess the efficacy and safety of the Food Supplement Physiomanna® Baby in pediatric patients with a history of functional constipation The secondary objective of the trial is to evaluate the adherence to product's administration in the enrolled children.

Detailed Description
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This is an interventional, non-controlled, multicenter trial with a prospective design in one cohort of patients. This clinical investigation will be performed in 3 centers in Romania. The tested hypothesis is that Physiomanna® Baby administration for 3 weeks, increases the SBM to be more than 2 times per week.

Official Title
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An Open Label, Non-comparative Pilot Study to Assess the Efficacy and Safety of the Food Supplement Physiomanna® Baby in Pediatric Patients With a History of Functional Constipation

Conditions
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Irritable Bowel Syndrome Characterized by Constipation

Intervention / Treatment
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* Dietary Supplement: Physiomanna® Baby


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female outpatients between the ages of 0 to 8 years; Functional constipation according to ROME III criteria (Annex 2); Two or fewer SBM during the previous week; SBM is defined as BM not preceded after a 24 h administration with a laxative or enema; To be otherwise in good health, as judged by a physical examination; Mentally competent parent or tutor to sign an informed consent Exclusion Criteria: Known history of organic cause for the constipation; Congenital malformations that produce constipation (Hirschsprung's disease, imperforate anus, children with cerebral palsy or other neurologic abnormalities, or systemic diseases); Fecal Occult Blood Test (FOBT) positive in the 4 previous weeks; Fecal impaction at baseline, or during the trial period, as indicated by the physical examination; Known or suspected perforation or obstruction other than fecal impaction; History of gastric retention, inflammatory bowel disease, bowel resection, or colostomy; Use of concomitant medications that cause constipation in the previous 3 months; Concomitant use of herbs and other dietary supplements, such as: stimulant laxative herbs and/or potassium depleting herbs; Concomitant use of cardiac glycosides(e.g. Digoxin); Patients who, according to the investigator, should not be included in the study for any reason, including the parent's inability to follow the study procedures; Patients with known allergy to Fraxinus Manna, mannitole, fennel, lemon balm or chamomile; Patients with clinically significant elevations of TSH or abnormal plasma electrolytes in the 4 previous weeks; Patients who, within the past 30 days have participated in an investigational clinical study;

Ages Eligible for Study
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Minimum Age: 1 Week
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Food Supplement Physiomanna® Baby<br>Dosage: 1g/kg body | Dietary Supplement: Physiomanna® Baby<br>* Dosage 1g/kg body, 2 cycles (if applicable)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Spontaneous Bowel Movements (SBM) per week |  | 2-3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Adverse Events (AE) check; Investigator and Patient Global Assessment |  | 2-3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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childhod constipation