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

Randomized clinical trial double-blind efficacy of Prebiotics in Chronic Constipation Funcinal in infants

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2x8wqc
Enrollment
Unknown
Registered
2015-06-24
Start date
2011-09-16
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipation, infants, treatment with fructooligosaccharides

Interventions

Infants who do not receive breast milk, aged 6 to 24 months, presenting diagnosis of Chronic Functional Constipation (CCF) and not have anemia, will be invited to participate in the project. For those
your bowel habits, nutritional status (taking into account the weight z-score for age) and eating habits. Moreover, they are also asked CBC (in venous blood, iron deficiency anemia was diagnosed when
Dietary supplement

Sponsors

Universidade Federal de São Paulo
Lead Sponsor
SKL Functional Nutrition
Collaborator

Eligibility

Age
6 Months to 24 Months

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
- Improvement of constipation in infants receiving the prebiotic (fructooligosaccharide); - 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 .; - An improvement of constipation around 70% in the group will receive the prebiotics (fructooligosaccharides) is expected.

Secondary

MeasureTime frame
Secondary outcomes are not expected.

Countries

Brazil

Contacts

Public ContactDaniela;Mauro Souza;Morais

Universidade Federal de São Paulo;Universidade Federal de São Paulo

danielasouza.nutri@gmail.com;mbmorais@osite.com.br+55 (13) 34946180;+55 (11) 5576-4857

Outcome results

None listed

Source: REBEC (via WHO ICTRP)