Food Supplement Physiomanna® Baby in Pediatric Patients

October 22, 2019 updated by: Iuppa Industriale Srl

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
    • Timis
      • Timisoara, Timis, Romania, 300209
        • Opera Contract Research Organization SRL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 week to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Food Supplement Physiomanna® Baby
Dosage: 1g/kg body
Dietary supplement: Physiomanna® Baby
Dosage 1g/kg body, 2 cycles (if applicable)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Iuppa Industriale Srl

Collaborators

Opera CRO, a TIGERMED Group Company

Investigators

  • Study Director: Barattini Dionisio, MD, OPERA CRO

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

March 31, 2016

First Submitted That Met QC Criteria

April 7, 2016

First Posted (Estimate)

April 11, 2016

Study Record Updates

Last Update Posted (Actual)

October 24, 2019

Last Update Submitted That Met QC Criteria

October 22, 2019

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IU01/016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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