Food Supplement Physiomanna® Baby in Pediatric Patients

NCT02732743 | Completed DMC

• 1 other identifier: IU01/016
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome Characterized by Constipation

Keywords

childhod constipation

Outcome Measures

Primary Outcomes (1)

• Number of Spontaneous Bowel Movements (SBM) per week

  2-3 weeks

Secondary Outcomes (1)

• Safety: Adverse Events (AE) check; Investigator and Patient Global Assessment

  2-3 weeks

Other Outcomes (2)

• Investigator and Patient Global Assessment for Efficacy

  2-3 weeks

• Analysis of product's administration adherence by diary cards

  2-3 weeks

Study Arms (1)

Food Supplement Physiomanna® Baby

OTHER

Dosage: 1g/kg body

Dietary Supplement: Physiomanna® Baby

Interventions

Physiomanna® Baby DIETARY_SUPPLEMENT

Dosage 1g/kg body, 2 cycles (if applicable)

Food Supplement Physiomanna® Baby

Eligibility Criteria

• Age: 1 Week - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Iuppa Industriale Srl: lead
• Opera CRO, a TIGERMED Group Company: collaborator

Study Sites (1)

Opera Contract Research Organization SRL

Timișoara, Timiș County, 300209, Romania

Location

Related Publications (7)

• 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.

  PMID: 21701812 BACKGROUND

• 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.

  PMID: 21949142 BACKGROUND

• 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.

  PMID: 14993586 BACKGROUND

• 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.

  PMID: 19087388 BACKGROUND

• 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.

  PMID: 23850543 BACKGROUND

• 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.

  PMID: 8591845 BACKGROUND

• 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.

  PMID: 19196035 BACKGROUND

Study Officials

• Barattini Dionisio, MD

  Opera CRO

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2016
• First Posted: April 11, 2016
• Study Start: February 1, 2016
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: October 24, 2019

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)