Georgieva M, Manios Y, Rasheva N, Pancheva R, Dimitrova E, Schaafsma A. Effects of carob-bean gum thickened formulas on infants’ reflux and tolerance indices. World J Clin Pediatr 2016; 5(1): 118-127 [PMID: 26862511 DOI: 10.5409/wjcp.v5.i1.118]
Corresponding Author of This Article
Miglena Georgieva, MD, PhD, Associate Professor, Second Pediatric Clinic, University Hospital ”St. Marine”, 1 Christo Smirnenski Avenue, 9000 Varna, Bulgaria. mgeorgieva7@yahoo.com
Research Domain of This Article
Nutrition & Dietetics
Article-Type of This Article
Randomized Clinical Trial
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Georgieva M, Manios Y, Rasheva N, Pancheva R, Dimitrova E, Schaafsma A. Effects of carob-bean gum thickened formulas on infants’ reflux and tolerance indices. World J Clin Pediatr 2016; 5(1): 118-127 [PMID: 26862511 DOI: 10.5409/wjcp.v5.i1.118]
World J Clin Pediatr. Feb 8, 2016; 5(1): 118-127 Published online Feb 8, 2016. doi: 10.5409/wjcp.v5.i1.118
Effects of carob-bean gum thickened formulas on infants’ reflux and tolerance indices
Miglena Georgieva, Yannis Manios, Niya Rasheva, Ruzha Pancheva, Elena Dimitrova, Anne Schaafsma
Miglena Georgieva, Niya Rasheva, Elena Dimitrova, Second Pediatric Clinic, University Hospital ”St. Marine”, 9000 Varna, Bulgaria
Yannis Manios, Department of Nutrition and Dietetics, Harokopio University of Athens, 17671 Kallithea, Athens, Greece
Ruzha Pancheva, Department of Hygiene, Medical University, 9000 Varna, Bulgaria
Anne Schaafsma, Friesland Campina, Stationsplein 4, 3800 BN Amersfoort, the Netherlands
Author contributions: Georgieva M and Schaafsma A conceived and designed the research; Georgieva M, Rasheva N, Pancheva R and Dimitrova E conducted the research; Georgieva M, Manios Y and Schaafsma A conducted the literature review; Manios Y lead the statistical analyses with the contribution and input from all authors; all authors took part in writing and revising the manuscript.
Supported by A research grant from FrieslandCampina.
Institutional review board statement: The study was reviewed and approved by the Medical Ethical Committee of the “St. Marina” University Hospital of Varna (Ethical approval No. 13/03.28.2013) and was implemented in accordance to the signed protocol and the rules for good clinical practice.
Clinical trial registration statement: The study is registered at http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4334. The registration identification number is NTR4334.
Informed consent statement: Written informed consent was obtained from the parents of all infants that were found to be eligible to be included in the study, prior to study enrollment.
Conflict-of-interest statement: Anne Schaafsma works for Friesland Campina. None of the other authors has any conflicts of interest to declare.
Data sharing statement: No further data is available.
Correspondence to: Miglena Georgieva, MD, PhD, Associate Professor, Second Pediatric Clinic, University Hospital ”St. Marine”, 1 Christo Smirnenski Avenue, 9000 Varna, Bulgaria. mgeorgieva7@yahoo.com
Telephone: +359-89-9074268 Fax: +359-52-302874
Received: July 14, 2015 Peer-review started: July 17, 2015 First decision: October 21, 2015 Revised: November 4, 2015 Accepted: November 10, 2015 Article in press: November 10, 2015 Published online: February 8, 2016 Processing time: 197 Days and 17.6 Hours
Core Tip
Core tip: The present study showed that Formula A was more effective in decreasing esophageal acid exposure, the total daily number of visible and measurable refluxes, as well as acid reflux related symptoms, while such changes were not observed for the infants fed with Formulas B and C. Furthermore, a significant increase of body weight was observed for infants fed with Formulas A and C while that was not observed for infants fed with Formula B, probably due to the increased number of diarrheic and total defecations recorded in this group. These findings indicate that Formula A, containing 0.33 g/100 mL of cold soluble galactomannans, seems to be more effective in reducing certain pH-monitoring indices of uncomplicated gastro-esophageal reflux, increasing body weight and being well-tolerated by infants.
