Evaluation of a therapy for the treatment of constipation in infants.

Not Applicable

Recruiting

• Conditions: Constipation, infants, treatment with fructooligosaccharides; C23.888.821.150

• Registration Number: RBR-2x8wqc
• Lead Sponsor: niversidade Federal de São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-24
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Infants attending for the first time in the Department of Ambulatory Pediatric Gastroenterology at UNIFESP - EPM;
Hypothesis diagnosis of chronic functional constipation;
Infants (children under two years old);
Infants of both genders; 6-24 months;
Infants artificial feeding
(over six months old).

Exclusion Criteria

Infants with clinical signs and symptoms suggestive of Hirschsprung's disease, including: delay in the elimination of meconium, growth retardation, abnormalities in skin pigmentation, presence of extra-intestinal symptoms and lack of response to conventional treatment (Aguirre et al, 2002 );
infants who had an organic cause of constipation, secondary to other pathologies, such as deformities in the gastrointestinal tract, hypothyroidism, rickets, malnutrition, Chagas disease or neuromuscular diseases (Cury, 2005);
Infants who present False constipation;
Infants who have anemia or iron deficiency are iron therapy with ferrous sulfate;
Hypothesis diagnosis of chronic functional constipation discarded after the first week of observation in the study;
Regular use over the past thirty days, dietary fiber supplement;
Chronic use of medications that act on intestinal motility and cause constipation (prokinetics, antacids, anticonvulsants, diuretics, hematin, antispasmodics, anti-inflammatories), with the exception of ferrous sulfate;
Need other therapeutic interventions;
Infants who had poor nutritional status, malnutrition or obesity;
Children living in cities or neighborhoods whose distance to the clinic or family socioeconomic conditions that preclude their attendance at scheduled follow-up visits;
Infants who were exclusively breastfed or mixed;
Infants who make use of formulas containing prebiotics;
Parents or guardians illiterate, who can not help of another person literate in child care during follow-up project;
Not responsible for the child's consent to participate.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Improvement of constipation in infants receiving the prebiotic (fructooligosaccharide);<br>- Verified by means of diagnosis of constipation (elimination of mandatory hard stools and the occurrence of at least one of the following: painful or difficult defecation, stool with cíbalos format, cylindrical or cylindrical with cracks; defecation frequency less than or equal to two times a week) from reported by parents in the child's daily .;<br>- An improvement of constipation around 70% in the group will receive the prebiotics (fructooligosaccharides) is expected.<br>

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes are not expected.<br>