NCT01021475

Brief Summary

The goal of this study is to determine if Visceral Manipulation (VM) is effective in treating Functional Dyspepsia in addition to drug therapy. Null hypothesis is that VM does not influence FD symptoms.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

November 27, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 30, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Last Updated

November 30, 2009

Status Verified

November 1, 2009

Enrollment Period

1 year

First QC Date

November 27, 2009

Last Update Submit

November 27, 2009

Conditions

Functional Dyspepsia

Keywords

Functional Dyspepsia, Visceral Manipulation

Outcome Measures

Primary Outcomes (1)

  • FD symptoms: Bothersome postprandial fullness / Early satiation / Epigastric pain / Epigastric burning

    baseline, 1, 4 and 8 weeks after therapy start

Study Arms (2)

Usual drug FD therapy + Visceral Manipulation

EXPERIMENTAL
Procedure: Visceral Manipulation

Usual drug FD therapy

ACTIVE COMPARATOR
Drug: PPIs and/or Domperidone

Interventions

Visceral ManipulationPROCEDURE

Usual FD drug therapy (PPIs and/or Domperidone in base of symptom complain) for 4 weeks and 4 VM visits with weekly frequency with first VM visit at day 1 of drug therapy.

Usual drug FD therapy + Visceral Manipulation
PPIs and/or DomperidoneDRUG

Usual FD drug therapy (PPIs and/or Domperidone in base of symptom complain) for 4 weeks

Usual drug FD therapy

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of Functional Dyspepsia

You may not qualify if:

  • Diabetes Mellitus
  • Mental disturbance
  • Thyroid gland dysfunction
  • Intestinal, liver and biliary tract disease
  • Concurrent medications that could interact with GI function
  • Positive Helicobacter Pylori status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ambulatori Comunali di Cavenago Brianza

Cavenago di Brianza, Milano, 20040, Italy

RECRUITING

Study Officials

  • Rossi Massimo, DO B.Sc (student)

    International College of Osteopathic Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Massimo Rossi, DO B.Sc (Student)

CONTACT

00393929517349massimo@rossimassimo.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 27, 2009

First Posted

November 30, 2009

Study Start

November 1, 2009

Primary Completion

November 1, 2010

Last Updated

November 30, 2009

Record last verified: 2009-11

Locations

IT(1)