- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02732743
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
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
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Timis
-
Timisoara, Timis, Romania, 300209
- Opera Contract Research Organization SRL
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
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
Sponsor
Collaborators
Investigators
- Study Director: Barattini Dionisio, MD, OPERA CRO
Publications and helpful links
General Publications
- Tabbers MM, Boluyt N, Berger MY, Benninga MA. Clinical practice : diagnosis and treatment of functional constipation. Eur J Pediatr. 2011 Aug;170(8):955-63. doi: 10.1007/s00431-011-1515-5. Epub 2011 Jun 24.
- Tabbers MM, Boluyt N, Berger MY, Benninga MA. Nonpharmacologic treatments for childhood constipation: systematic review. Pediatrics. 2011 Oct;128(4):753-61. doi: 10.1542/peds.2011-0179. Epub 2011 Sep 26.
- Loening-Baucke V, Miele E, Staiano A. Fiber (glucomannan) is beneficial in the treatment of childhood constipation. Pediatrics. 2004 Mar;113(3 Pt 1):e259-64. doi: 10.1542/peds.113.3.e259.
- Livesey G. Health potential of polyols as sugar replacers, with emphasis on low glycaemic properties. Nutr Res Rev. 2003 Dec;16(2):163-91. doi: 10.1079/NRR200371.
- Caligiani A, Tonelli L, Palla G, Marseglia A, Rossi D, Bruni R. Looking beyond sugars: phytochemical profiling and standardization of manna exudates from Sicilian Fraxinus excelsior L. Fitoterapia. 2013 Oct;90:65-72. doi: 10.1016/j.fitote.2013.07.002. Epub 2013 Jul 10.
- Kountouras J, Magoula I, Tsapas G, Liatsis I. The effect of mannitol and secretin on the biliary transport of urate in humans. Hepatology. 1996 Feb;23(2):229-33. doi: 10.1053/jhep.1996.v23.pm0008591845.
- Taylor SN, Basile LA, Ebeling M, Wagner CL. Intestinal permeability in preterm infants by feeding type: mother's milk versus formula. Breastfeed Med. 2009 Mar;4(1):11-5. doi: 10.1089/bfm.2008.0114.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
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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