NCT04381793

Brief Summary

The study will explore if Recovery Factors improve symptoms in fibromyalgia and chronic fatigue syndrome

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

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

May 20, 2019

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 11, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2020

Completed
Last Updated

October 19, 2020

Status Verified

February 1, 2020

Enrollment Period

1.1 years

First QC Date

May 6, 2020

Last Update Submit

October 15, 2020

Conditions

FibromyalgiaChronic Fatigue Syndrome

Outcome Measures

Primary Outcomes (1)

  • VAS

    Composite VAS (1-10) for Fatigue, Pain, Cognition, Sleep and overall well-being

    6 weeks

Secondary Outcomes (2)

  • antibody titres

    10 weeks

  • FIQ-R

    6 weeks

Study Arms (1)

Assessing clinical efficacy

EXPERIMENTAL

Subjects will receive four tablets twice a day (three times a day for five day loading dose), taking the treatment for 5 - 6 weeks. The treatment is a unique nutritional peptide mix derived from porcine serum. Pre-and post FIQ-R and VA symptom score will be assessed as well as overall well-being. In a subgroup, pre-and post antibody levels will also be checked. Phase 1 will be a group of 60 subjects

Dietary Supplement: Recovery Factors

Interventions

Recovery FactorsDIETARY_SUPPLEMENT

Porcine serum amino acid/peptide

Assessing clinical efficacy

Eligibility Criteria

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

You may qualify if:

  • Meet ACR 2010 amended Fibromyalgia criteria or CDC CFS Criteria Overall well being score of 5 of less (on 0-10 VAS)

You may not qualify if:

  • Pregnant Clotting disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jacob Teitelbaum MD

Kailua, Hawaii, 96740, United States

Location

MeSH Terms

Conditions

FibromyalgiaFatigue Syndrome, Chronic

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesEncephalomyelitisNeuroinflammatory DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gaetano Morello, ND

    Woman's Hospital in Vancouver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Open pilot study to assess efficacy and antibody effects
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2020

First Posted

May 11, 2020

Study Start

May 20, 2019

Primary Completion

July 4, 2020

Study Completion

July 4, 2020

Last Updated

October 19, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)