Treament of Rumination

NCT04167371 | Completed

• 1 other identifier: PR(AG)373/2019
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Background. Rumination syndrome is characterized by effortless recurrent regurgitation of recently ingested food into the mouth, with consequent expulsion or re-chewing and swallowing. In a previous study we showed that rumination is produced by an unperceived, somatic response to food ingestion. We developed an original biofeedback technique based on electromyography-guided control of abdominothoracic muscular activity. In a randomized, placebo-controlled trial we demonstrated the superiority of biofeedback over placebo for the treatment of rumination. However, the technique is technically complex and unpractical. Aim. To prove the efficacy of a simplified biofeedback technique for the treatment of rumination. Selection criteria. Rumination after meal ingestion. Intervention. Patients will be randomized into biofeedback in placebo groups. Three sessions of either biofeedback or placebo intervention will be performed after ingestion of a probe meal during the first 3 weeks of the 4 weeks intervention period. Biofeedback: patients will be taught to control abdominal and thoracic muscular activity by providing a visual display of the abdominal and thoracic perimeter; patients will be instructed to perform the same exercises before and after breakfast, lunch and dinner during the 4-week intervention period. Placebo: abdominal and thoracic perimeter will be recorded but not shown to the patient and a pill of placebo containing 0.5 g glucose will be administered; patients will be instructed to take a pill of placebo before breakfast, lunch and dinner during the 4-week intervention period. Primary Outcome Measure: Number of rumination events measured by electromyography in response to the challenge meal before and after treatment. Secondary Outcome Measures:

• Number of self perceived rumination events measured by questionnaires administered daily for 10 days will before and after treatment.
• Associated abdominal symptom measured by questionnaires administered daily for 10 days before and after treatment.
• Follow up: number of self perceived rumination events measured at 1, 3 and 6 months after treatment.

Conditions

Rumination Disorders

Outcome Measures

Primary Outcomes (1)

• Number of rumination events after a challenge meal measured by electromyography

  Rumination events will be identified by recording the activity of the thoraco abdominal muscles (intercostals, external oblique, internal oblique, upper rectus, lower rectus) by electromyography after a challenge meal. The response to the meal will be measured before and after treatment.

  4 weeks

Secondary Outcomes (3)

• Number of self perceived rumination events.

  4 weeks

• Abdominal discomfort.

  4 weeks

• Number of self perceived rumination events up to 6 months.

  up to 6 months

Study Arms (2)

Biofeedback

EXPERIMENTAL

Behavioral: Biofeedback

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Biofeedback BEHAVIORAL

Three sessions by biofeedback will be performed during the first 3 weeks of the intervention period. In each session patients will be taught to control abdominal and thoracic muscular activity by providing a visual display of the abdominal and thoracic perimeter; patients will be instructed to perform the same exercises before and after breakfast, lunch and dinner during the 4-week intervention period.

Biofeedback

Placebo DIETARY_SUPPLEMENT

Three sessions will be performed during the first 3 weeks of the intervention period. In each session abdominal and thoracic perimeter will be recorded but not shown to the patient; patients will take a pill of placebo containing 0.5 g glucose and no specific instructions will be provided. Patients will be instructed to take a pill of placebo before breakfast, lunch and dinner during the 4-week intervention period.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Rumination syndrome

You may not qualify if:

• Relevant organic diseases

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Vall d'Hebron Research Institute

Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Rumination Syndrome

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: November 18, 2019
• Study Start: December 2, 2019
• Primary Completion: October 30, 2020
• Study Completion: February 1, 2022
• Last Updated: February 14, 2022

Record last verified: 2020-12

Locations

ES (1)