Food Supplement Physiomanna® Baby in Pediatric Patients

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02732743

Enrollment

Registered

2016-04-11

Start date

2016-02-29

Completion date

2016-04-30

Last updated

2019-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome Characterized by Constipation

Keywords

childhod constipation

Brief summary

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

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.

Interventions

DIETARY_SUPPLEMENTPhysiomanna® Baby

Dosage 1g/kg body, 2 cycles (if applicable)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Weeks to 8 Years

Healthy volunteers

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;

Design outcomes

Primary

Measure	Time frame
Number of Spontaneous Bowel Movements (SBM) per week	2-3 weeks

Secondary

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

Other

Measure	Time frame
Analysis of product's administration adherence by diary cards	2-3 weeks
Investigator and Patient Global Assessment for Efficacy	2-3 weeks

Countries

Romania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026