Constipation

Constipation

For each infant trouble or a combination of troubles,
Novalac offers an adapted nutritional solution.

The pathophysiology of functional constipation in children remains unclear but is likely multifactorial.

It is often the result of repeated attempts of voluntary withholding feces to avoid unpleasant and painful experiences with defecation. Stool retention leads the colon to absorb more water, creating hard stools that are more difficult to evacuate. This vicious circle of stool retention can lead to fecal impaction, sometimes to overflow fecal incontinence, loss of rectal sensation, and ultimately, loss of normal urge to defecate 1.

In the first years of life, a change in diet may also lead to an acute episode of constipation with dry, hard stools, potentially causing painful bowel movements 2. In toddlers, the onset of constipation may coincide with toilet training 2. Other factors may include stress, genetics, intestinal dysbiosis or abnormalities in muscles related to defecation 1.

In literature, prevalence of functional constipation in the 1st year of life varies between 0.05% to 39.3% 3, this large range being probably due to differences across studies in their design, their setting, and the diagnosis criteria used. The worldwide prevalence of functional constipation diagnosed according to Rome IV criteria is up to 16% in infants aged 0-12 months and up to 18.5% in children aged 12-48 months 4. In a European study, constipation was the most common functional disorders among infants aged 13 to 48 months, with a prevalence of 9.7% based on Rome IV criteria 5.  

The goal for treating functional constipation is to break the vicious circle, to restore a regular defecation pattern and to prevent relapses 6. Dietary management through the use of an adapted infant formula in non-breastfed infants can be an excellent option in the management of functional constipation while reducing the excessive and inappropriate use of medications 6.

  1. Levy, E. I., Lemmens, R., Vandenplas, Y. & Devreker, T. Functional constipation in children: challenges and solutions. Pediatr. Health Med. Ther. 8, 19–27 (2017).
  2. Benninga, M. A. et al. Childhood Functional Gastrointestinal Disorders: Neonate/Toddler. Gastroenterology 150, 1443–1455 (2016).
  3. Vandenplas, Y. et al. Prevalence and Health Outcomes of Functional Gastrointestinal Symptoms in Infants From Birth to 12 Months of Age. J. Pediatr. Gastroenterol. Nutr. 61, 531–537 (2015).
  4. Muhardi, L. et al. A Narrative Review on the Update in the Prevalence of Infantile Colic, Regurgitation, and Constipation in Young Children: Implications of the ROME IV Criteria. Front. Pediatr. 9, 778747 (2022).
  5. Steutel, N. F. et al. Prevalence of Functional Gastrointestinal Disorders in European Infants and Toddlers. J. Pediatr. 221, 107–114 (2020).
  6. Salvatore, S. et al. Review shows that parental reassurance and nutritional advice help to optimise the management of functional gastrointestinal disorders in infants. Acta Paediatr. Oslo Nor. 1992 (2018).

Clinical trials and studies

The efficacy of Novalac formulas is evidenced in published clinical trials. Amongst them are some of the largest studies ever performed to date on anti-regurgitation formulas, extensively hydrolyzed formulas, and elemental (amino-acid) formulas.

2019

Constipation – Controlled randomized trial

Magnesium-rich formula for functional constipation in infants: a randomized comparator-controlled study

Pediatric Gastroenteroly, Hepatology & Nutrition, 2019 May, 22(3):270-281

Benninga Marc A, Mena Infant Constipation Study Group, Vandenplas Y

The aim is to compare the effectiveness of the magnesium (Mg)-enriched formula vs. control formula in constipated infants.

2011

Biochemical evidence

Modification of stool’s water content in constipated infants: management with an adapted infant formula

Nutrition Journal, 2011, 10:55

Infante DD, Segarra OO, Redecillas SS, Alvarez MM, Miserachs MM

Constipation is a common occurrence in formula-fed infants. The aim of this preliminary study was to evaluate the impact of a formula with high levels of lactose and magnesium, in compliance with the official regulations, on stool water content, as well as a parental assessment of constipation.

2008

Prevalence of GI disorders – Efficacy in management

Prevalence and dietetic management of mild gastrointestinal disorders in milk-fed infants

World Journal of Gastroenterology, 2008, 14(2):248-54

Infante Pina D, Badia Llach X, Ariño-Armengol B, Villegas Iglesias V

The aim is to assess the prevalence of mild gastrointestinal disorders in milk-fed infants in paediatric practice, and to evaluate the effectiveness and satisfaction with dietetic treatment.

2007

Efficacy

Therapeutic effect of Novalac-IT in infants with constipation

Nutrition, 2007, 23(6):469-73

Chao HC, Vandenplas Y

Infant constipation is a frequent condition in formula-fed infants.

A prospective randomized clinical trial was performed in infants who had constipation with Novalac-IT (IT group) versus a 20% strengthened formula (S group). Enrolled subjects had difficulties in defecating, hard stools, or low frequency of defecation (< or =3 times/wk) (…).

2002

Hirschsprung’s disease, prevention of constipation

Preventive use of a milk causing intestinal hyperosmolarity, from infants having operated for Hirschsprung’s disease

Revue Internationale de Pédiatrie, 2002, Tome XXXIII, n° 319:28-30

Smarropoulos E, Liolios N, Netskos D, Anagnostopoulos D

Constipation may be early or a late complication of the surgical management, according to the Duhamel procedure, in infants affected by Hirschsprung’s disease. The present study aims to assess the response of infant’s gastrointestinal system towards the follow-on formula Novalac IT2. The aspect and frequency of the stools as well as the characteristics of defecation are observed in two groups of 5 infants each fed either Novalac IT2 or standard follow-on formula.

The results are impressive from the first 24 hours with the observation of soft stools in every infant fed with Novalac IT2. Novlaac IT2 promotes intestinal intraluminal osmolarity leading to normal defecations associated with minimal discomfort, as well as parents’ reassurance who saw for the first time their child relieved.

Furthermore, none of the subjects fed with Novalac IT2 ever visited again the hospital because of constipation, meaning economy for both, families and medical personnel.