NCT01400048

Brief Summary

The purpose of the present study is to study the effect of aloe vera in the treatment of IBS patients in a randomized, double-blind placebo controlled study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
173

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2010

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 22, 2011

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

September 10, 2018

Status Verified

September 1, 2018

Enrollment Period

6.9 years

First QC Date

July 19, 2011

Last Update Submit

September 7, 2018

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

  • IBS symptoms

    4 weeks

Study Arms (2)

Aloe vera effervescent tablet (AVH200)

ACTIVE COMPARATOR
Dietary Supplement: Aloe vera effervescent tablet (AVH200)

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo control

Interventions

Aloe vera effervescent tablet (AVH200)DIETARY_SUPPLEMENT

250 mg aloe vera and 60 mg ascorbic acid, Aloe Life®

Aloe vera effervescent tablet (AVH200)
Placebo controlDIETARY_SUPPLEMENT

60mg Ascorbic acid

Placebo

Eligibility Criteria

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

You may qualify if:

  • IBS according to the Rome III criteria
  • Adults

You may not qualify if:

  • other GI disorders
  • other medical conditions
  • were pregnancy or breast-feeding
  • food allergy or intolerance to other than lactose
  • ongoing intake of aloe vera products

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mag-tarmlab, Dept of Internal Medicine, Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

Location

Related Publications (1)

  • Ahluwalia B, Magnusson MK, Bohn L, Storsrud S, Larsson F, Savolainen O, Ross A, Simren M, Ohman L. Randomized clinical trial: Effects of Aloe barbadensis Mill. extract on symptoms, fecal microbiota and fecal metabolite profiles in patients with irritable bowel syndrome. Neurogastroenterol Motil. 2020 Aug;32(8):e13860. doi: 10.1111/nmo.13860. Epub 2020 Apr 20.

    PMID: 32314514DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Magnus Simrén, MD, PhD

    Dept of Internal medicine, Sahlgrenska UH, Gothenburg, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 19, 2011

First Posted

July 22, 2011

Study Start

January 1, 2010

Primary Completion

December 1, 2016

Study Completion

March 1, 2017

Last Updated

September 10, 2018

Record last verified: 2018-09

Locations

SE(1)