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Food Supplement Physiomanna® Baby in Pediatric Patients

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ClinicalTrials.gov Identifier: NCT02732743
Recruitment Status : Completed
First Posted : April 11, 2016
Last Update Posted : January 16, 2018
Sponsor:
Collaborator:
Opera Contract Research Organization SRL
Information provided by (Responsible Party):
Iuppa Industriale Srl

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.


Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Characterized by Constipation Dietary Supplement: Physiomanna® Baby Not Applicable

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  (Clinical Trial)
Actual Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: 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
Study Start Date : February 2016
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Food Supplement Physiomanna® Baby
Dosage: 1g/kg body
Dietary Supplement: Physiomanna® Baby
Dosage 1g/kg body, 2 cycles (if applicable)




Primary Outcome Measures :
  1. Number of Spontaneous Bowel Movements (SBM) per week [ Time Frame: 2-3 weeks ]

Secondary Outcome Measures :
  1. Safety: Adverse Events (AE) check; Investigator and Patient Global Assessment [ Time Frame: 2-3 weeks ]

Other Outcome Measures:
  1. Investigator and Patient Global Assessment for Efficacy [ Time Frame: 2-3 weeks ]
  2. Analysis of product's administration adherence by diary cards [ Time Frame: 2-3 weeks ]


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Ages Eligible for Study:   up to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02732743


Locations
Romania
Opera Contract Research Organization SRL
Timisoara, Timis, Romania, 300209
Sponsors and Collaborators
Iuppa Industriale Srl
Opera Contract Research Organization SRL
Investigators
Study Director: Barattini Dionisio, MD Opera CRO

Publications:
Responsible Party: Iuppa Industriale Srl
ClinicalTrials.gov Identifier: NCT02732743     History of Changes
Other Study ID Numbers: IU01/016
First Posted: April 11, 2016    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Iuppa Industriale Srl:
childhod constipation

Additional relevant MeSH terms:
Constipation
Irritable Bowel Syndrome
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases