The Effect of Bifidobacterium Lactis and Inulin on Functional Constipation

Eskisehir Osmangazi University

Status: Unknown

Conditions: Functional Constipation

Treatments: Other: B.Lactis +Inulin; Other: B.lactis; Other: Placebo; Other: Inulin

Study type: Interventional

Funder types: Other

Identifiers

NCT01913665

not defined yet

Details and patient eligibility

About

The aim of this study is to asses the effect of Bifidobacterium lactis and Inulin on functional constipation in children

Enrollment: 200 estimated patients

Sex: All

Ages: 4 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• children with functional constipation over 3 years age
• below 18 years of age

Exclusion criteria

• Chronic gastrointestinal disease,
• hirschsprung disease,
• celiac disease,
• hypothyroids,
• neurological deficit,
• constipation treatment receiving children will be excluded

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 4 patient groups, including a placebo group

B.Lactis

Active Comparator group

Description:

children with functional constipation

Treatment:

Other: B.lactis

Inulin

Active Comparator group

Description:

children with functional constipation

Treatment:

Other: Inulin

B.Lactis+ınulin

Active Comparator group

Description:

children with functional constipation

Treatment:

Other: B.Lactis +Inulin

plasebo

Placebo Comparator group

Description:

children with functional constipation

Treatment:

Other: Placebo