Food Supplement Physiomanna® Baby in Pediatric Patients

Irritable Bowel Syndrome Characterized by Constipation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02732743
• Other study ID #: IU01/016
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: April 2016

Study information

• Verified date: March 2017
• Source: Iuppa Industriale Srl
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 8 Years

Eligibility

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;

Related Conditions & MeSH terms

• Constipation
• Irritable Bowel Syndrome
• Irritable Bowel Syndrome Characterized by Constipation

Intervention

Dietary Supplement:
• Physiomanna® Baby
Dosage 1g/kg body, 2 cycles (if applicable)

Locations

Country	Name	City	State
Romania	Opera Contract Research Organization SRL	Timisoara	Timis

Sponsors (2)

Lead Sponsor	Collaborator
Iuppa Industriale Srl	Opera CRO, a TIGERMED Group Company

Country where clinical trial is conducted

Romania, 

References & Publications (7)

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. — View 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. — View Citation

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. — View 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. — View 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. Review. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Investigator and Patient Global Assessment for Efficacy		2-3 weeks
Other	Analysis of product's administration adherence by diary cards		2-3 weeks
Primary	Number of Spontaneous Bowel Movements (SBM) per week		2-3 weeks
Secondary	Safety: Adverse Events (AE) check; Investigator and Patient Global Assessment		2-3 weeks