NCT02660970

Brief Summary

Functional gastrointestinal disorders are common disorders that are characterized by persistent and recurring GI symptoms. These occur as a result of abnormal functioning of the GI tract and are not caused by structural or biochemical abnormalities. As a result, medical tests- such as blood tests and endoscopic exams- have essentially normal/negative (non-disease) results. More than 20 functional GI disorders have been identified. They can affect any part of the GI tract. One of the most common functional disorders is nausea and dyspepsia (pain or discomfort in the upper abdominal area, feeling of fullness, bloating). Any chronic illness, including functional nausea, will affect a person's health-related quality of life (general well-being, ability to carry out everyday activities), additional psychosocial disturbances and amplify the experienced illness. The majority of children suffering from functional nausea in Europe are treated with Iberogast®. a herbal mixture, whose effect was demonstrated in several studies. Since Iberogast® is not available in the United States of America, children there receive an acupressure therapy. The American gastroenterologists refer hereby to several studies, which have shown, that the positive effect of such therapies in patients with chemotherapy-induced nausea is even greater than a therapy with ondansetron. Since acupressure is able to reduce somatic nausea, it is also believed to decrease functional nausea, but it has never been investigated. Therefore, there are no data. That's why Investigators want to compare the efficacy of these two therapies, that is, Iberogast® and acupressure

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

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, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 21, 2016

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2020

Completed
Last Updated

October 6, 2020

Status Verified

October 1, 2020

Enrollment Period

4.7 years

First QC Date

January 18, 2016

Last Update Submit

October 5, 2020

Conditions

Functional Nausea

Keywords

IberogastAcupressuregut-brain-axis

Outcome Measures

Primary Outcomes (1)

  • comparison in the levels of nausea as assessed by visual analog scales (VAS)

    4 weeks

Study Arms (4)

Acupressure

ACTIVE COMPARATOR

Children will have to wear a 'seasickness-band', which has the effect of acupressure

Other: Acupressure

Placebo-band

PLACEBO COMPARATOR

Children will have to wear a 'placebo-wristband'

Other: Placebo-band

Iberogast

ACTIVE COMPARATOR

Children will have to take Iberogast drops

Drug: Iberogast

Placebo-drops

PLACEBO COMPARATOR

Children will have to take placebo-drops

Other: Placebo-drops

Interventions

AcupressureOTHER

Children will have to wear a 'seasickness-band', which has the effect of acupressure

Also known as: Seasickness-Band
Acupressure
Placebo-bandOTHER

Children will have to wear a 'placebo-wristband'

Placebo-band
IberogastDRUG

Children will have to take Iberogast drops

Iberogast
Placebo-dropsOTHER

Children will have to take placebo-drops

Placebo-drops

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Functional nausea (normal endoscopy findings)

You may not qualify if:

  • Gastrointestinal infection less than 2 weeks ago
  • Known chronic gastrointestinal disease
  • Use of drugs 2 weeks prior to starting the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pedriatric Gastroenterology, University Children's Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

MeSH Terms

Interventions

Acupressureiberogast

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Raoul Furlano, MD, Dr

    University Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2016

First Posted

January 21, 2016

Study Start

January 1, 2016

Primary Completion

September 16, 2020

Study Completion

September 16, 2020

Last Updated

October 6, 2020

Record last verified: 2020-10

Locations

CH(1)