NCT01286376

Brief Summary

Determine the effectiveness of symbiotic LACTOFOS containing FOS and probiotics against placebo in patients with a diagnosis of constipation, comparing the average number of weekly evacuations in 2 (two) groups for 30 days.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 31, 2011

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

January 31, 2011

Status Verified

December 1, 2010

Enrollment Period

7 months

First QC Date

January 20, 2011

Last Update Submit

January 28, 2011

Conditions

Constipation

Keywords

SymbioticsFiberConstipation

Outcome Measures

Primary Outcomes (1)

  • Frequency of stool - Chart

    30 days taking 2 times per day. At morning and night

    30 days

Study Arms (2)

symbiotic

ACTIVE COMPARATOR
Dietary Supplement: Symbiotic Lactofos

placebo

PLACEBO COMPARATOR
Dietary Supplement: Maltodextrin

Interventions

Symbiotic LactofosDIETARY_SUPPLEMENT

Lactobacillus Paracasei Lactobacillus Rhamnosus Lactobacillus Acidophilus Bifidobacterium lactis 12g/day

Also known as: prebiotcs, probiotcs
symbiotic
MaltodextrinDIETARY_SUPPLEMENT

Maltodextrin

placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Females aged 18-75 years
  • A diagnosis of constipation defined by Rome III criteria
  • Ability to good communication with the investigator and agreeing to requests from the entire study
  • Patients must sign a formal consent to participate

You may not qualify if:

  • Constipation drug source
  • History or evidence of organic disease of the gastrointestinal tract such as tumors, inflammatory bowel disease, etc.. proven by radiological or endoscopic examination of the bowel (five years before and after onset of symptoms). If the investigator has doubts should request the necessary procedures, such as sigmoidoscopy, colonoscopy or edema bariatric to exclude organic disease
  • History of laxative use which in the opinion of the investigator is consistent with severe laxative dependence
  • Current History recent (12 months) of significant abuse of alcohol or drugs
  • History of malignancy in 5 (five) previous years (except basal cell carcinoma treated well or cervical carcinoma in situ)
  • Known history of cardiovascular control inappropriate and / or significant respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other illness which compromises the ability of patients to participate in the full study
  • Use of investigational drugs in the previous month or intentional use of such drugs during the study
  • Intention of regular use of other medications that affect intestinal motility and / or perceived
  • Lactose malabsorption is not treatable. If clinical suspicion of lactose intolerance, the procedure for proper diagnosis should be made to establish or exclude a diagnosis. If malabsorption is diagnosed, the patient should receive appropriate conditions of treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ganep Nutrição Humana

São Paulo, São Paulo, 01323-001, Brazil

RECRUITING

Related Publications (1)

  • Waitzberg DL, Logullo LC, Bittencourt AF, Torrinhas RS, Shiroma GM, Paulino NP, Teixeira-da-Silva ML. Effect of synbiotic in constipated adult women - a randomized, double-blind, placebo-controlled study of clinical response. Clin Nutr. 2013 Feb;32(1):27-33. doi: 10.1016/j.clnu.2012.08.010. Epub 2012 Aug 23.

    PMID: 22959620DERIVED

MeSH Terms

Conditions

Constipation

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dan L. Waitzberg, phd

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luciana Logullo

CONTACT

55-11-32846318pesquisa@ganep.com.br

Dan Waitzberg, phd

CONTACT

55-11-72662040pesquisa@ganep.com.br

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 20, 2011

First Posted

January 31, 2011

Study Start

August 1, 2010

Primary Completion

March 1, 2011

Study Completion

August 1, 2011

Last Updated

January 31, 2011

Record last verified: 2010-12

Locations

BR(1)