Clinical trial NCT02732743: Food Supplement Physiomanna® Baby in Pediatric Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome Characterized by Constipation
Keywords: childhod constipation
Lead sponsor: Iuppa Industriale Srl
Sponsor class: OTHER
Collaborators: name: Opera CRO, a TIGERMED Group Company
First posted: 2016-04-11
Enrollment: 45
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

Eligibility 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;

Primary outcomes:
measure: Number of Spontaneous Bowel Movements (SBM) per week
timeFrame: 2-3 weeks
Secondary outcomes:
measure: Safety: Adverse Events (AE) check; Investigator and Patient Global Assessment
timeFrame: 2-3 weeks
Other outcomes:
measure: Investigator and Patient Global Assessment for Efficacy
timeFrame: 2-3 weeks
measure: Analysis of product's administration adherence by diary cards
timeFrame: 2-3 weeks
Locations:
city: Timisoara
country: Romania
facility: Opera Contract Research Organization SRL
state: Timis
Study officials:
affiliation: Opera CRO
name: Barattini Dionisio, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.