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Trial registered on ANZCTR


Registration number
ACTRN12621001646831
Ethics application status
Approved
Date submitted
26/10/2021
Date registered
1/12/2021
Date last updated
14/12/2021
Date data sharing statement initially provided
1/12/2021
Date results provided
14/12/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Gastroparesis symptoms and its treatment using low-viscosity soluble dietary fibres
Scientific title
The Short-Term Effects and Tolerability of Low-Viscosity Soluble Fibre on Gastroparesis Patients: A Pilot Clinical Intervention Study
Secondary ID [1] 305662 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastroparesis 324127 0
Condition category
Condition code
Oral and Gastrointestinal 321607 321607 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each participant clinical study involved a total of four interventions (Over the course of four weeks). All interventions were given under supervised administration (Face-to-Face) at the MacArthur Clinical School, Western Sydney University (WSU), Campbelltown, NSW 2560, Australia. Each intervention session included a supervised 3.5 hours monitoring period where measurements were taken.

Interventions were delivered to participants by Harsha Suresh (Co-Investigator, PhD Candidate) under the supervision of Dr. Vincent Ho (Co-Investigator, Clinical Gastroeneterologist) and Dr. Jerry Zhou (Principal Investigator, Clinical Scientist).

The four interventions were Water (200 mL) as a negative control baseline and dietary fibres supplements (10 g in 200 mL) of Partially-hydrolysed guar gum (PHGG), Gum Arabic and Psyllium Husk. Psyllium Husk was assigned as the positive control.

Each intervention was followed by the supplementation of Actilax (10 mL) and a glucose challenge (50 grams in 300 mL). Each intervention (Water, PHGG, Gum Arabic & Psyllium Husk) was delivered only once for each participant.

The interventions were spaced 1-week apart from each other. The negative control (Water) intervention was given on Week 1 followed by dietary fibre interventions in Weeks 2, 3 & 4. The dietary fibre interventions (PHGG, Gum Arabic & Psyllium Husk) were given in randomized order (The order of dietary fibre interventions was different for each participant).
Intervention code [1] 322058 0
Treatment: Other
Comparator / control treatment
The comparator / control treatment for this study was Water (200 mL), assigned as negative control. The effects of all three dietary fibre interventions (Partially-hydrolysed guar gum (PHGG), Gum Arabic and Psyllium Husk) were compared to the negative control.

The effects of the 'low-viscosity' soluble fibres PHGG and Gum Arabic were compared to Psyllium Husk, assigned as positive control.
Control group
Active

Outcomes
Primary outcome [1] 329367 0
To compare the blood glucose regulation / control ability of 'low-viscosity' test fibres Partially-hydrolysed guar gum (PHGG) and Gum Arabic to the negative control (Water) and positive control (Psyllium Husk).

The blood glucose control of the interventions was assessed using pin-prick blood glucose values in response to the interventions, Actilax and the glucose challenge (50 g in 300 mL).
Timepoint [1] 329367 0
Pin-prick blood glucose values (mg/dL) were recorded at 30 min intervals (30 min, 60 min, 90 min, 120 min, 150 min, 180 min) for 3 hours after the administration of the glucose challenge drink (50 g in 300 mL). The glucose challenge was administered immediately after the supplementation of the dietary fibre intervention (10 g in 200 mL Water) or negative control (200 mL Water) and Actilax (10 mL).

The baseline pin-prick blood glucose value (0 min) was recorded immediately before the supplementation of each intervention, Actilax and blood glucose challenge drink.
Primary outcome [2] 329368 0
To compare the symptom severity / tolerability of 'low-viscosity' test fibres Partially-hydrolysed guar gum (PHGG) and Gum Arabic to the negative control (Water) and positive control (Psyllium Husk).

The tolerability of the interventions was assessed using the patient-rated American Neurogastroenterology and Motility Society - Gastroparesis Cardinal Symptom Index - Daily Diary (ANMS-GCSI-DD) in response to the interventions, Actilax and the glucose challenge (50 g in 300 mL).
Timepoint [2] 329368 0
Patient-rated ANMS-GCSI-DD symptom scores (0 -> 5; Least severe to Most severe) were recorded at 30 min intervals (30 min, 60 min, 90 min, 120 min, 150 min, 180 min) for 3 hours after the administration of the glucose challenge drink (50 g in 300 mL). The glucose challenge was administered immediately after the supplementation of the dietary fibre intervention (10 g in 200 mL Water) or negative control (200 mL Water) and Actilax (10 mL).

The baseline ANMS-GCSI-DD symptom scores (0 min) were recorded immediately before the supplementation of the each intervention, Actilax and blood glucose challenge drink.

ANMS-GCSI-DD symptom scores were measured for 'Nausea', 'Retching', 'Vomiting', 'Stomach fullness', 'Early satiety', 'Post-prandial fullness', 'Loss of appetite', 'Bloating' and 'Belly visibly larger'.
Secondary outcome [1] 402351 0
To compare the reaching / start of mouth-to-caecum transit of 'low-viscosity' test fibres Partially-hydrolysed guar gum (PHGG) and Gum Arabic to the negative control (Water) and positive control (Psyllium Husk).

The start of mouth-to-caecum transit of the interventions was assessed using a H2 + CH4 measurement breath test monitor in response to the interventions, Actilax and the glucose challenge (50 g in 300 mL).
Timepoint [1] 402351 0
Breath test measurements (H2 + CH4 breath test values in ppm) were recorded at 30 min intervals (30 min, 60 min, 90 min, 120 min, 150 min, 180 min) for 3 hours after the administration of the glucose challenge drink (50 g in 300 mL). The glucose challenge was administered immediately after the supplementation of the dietary fibre intervention (10 g in 200 mL Water) or negative control (200 mL Water) and Actilax (10 mL).

The baseline breath test measurement (0 min) was recorded immediately before the supplementation of each intervention, Actilax and blood glucose challenge drink.

Eligibility
Key inclusion criteria
Participants diagnosed with gastroparesis by their physician through a gastric scintigraphy (Tc-99m radio labelled) study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants requiring enteral feeding (i.e,, feeding tubes) were excluded.

Participants with allergies to wheat-based products were excluded (Celiac disease).

Participants with co-morbidities related to gastroparesis other than Type-1 or Type-2 diabetes were excluded.

Participants who were pregnant were excluded.

Participants who could not provide informed self-consent were excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The blood glucose control, ANMS-GCSI-DD and H2 + CH4 breath test measurement data of each participant was anonymised (Participant 1, Participant 2 etc,) before being used for statistical analysis.

The collected data was then 'normalized' to the baseline measurement (0 min) for each intervention and monitored parameter (Blood glucose, ANMS-GCSI-DD and H2 + CH4).

This made the curated data for each intervention and objective comparable across all recruited participants. The normalized data of each intervention was not weighted according to age, BMI, gender or severity of disease (Mild-to-moderate symptom gastroparesis).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/07/2018
Date of last participant enrolment
Anticipated
Actual
5/02/2020
Date of last data collection
Anticipated
Actual
30/11/2020
Sample size
Target
10
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 310021 0
University
Name [1] 310021 0
Western Sydney University
Country [1] 310021 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Building 30, School of Medicine, Western Sydney University
Goldsmith Ave, Campbelltown, NSW 2560, Australia
Country
Australia
Secondary sponsor category [1] 311077 0
None
Name [1] 311077 0
Address [1] 311077 0
Country [1] 311077 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309728 0
Western Sydney University Human Research Ethics Committee (HREC)
Ethics committee address [1] 309728 0
Ethics committee country [1] 309728 0
Australia
Date submitted for ethics approval [1] 309728 0
29/06/2017
Approval date [1] 309728 0
12/07/2017
Ethics approval number [1] 309728 0
H12254

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115190 0
Dr Jerry Zhou
Address 115190 0
Dr Jerry Zhou
School of Medicine, Western Sydney University
Locked Bag 1797, Penrith South DC NSW 2751
Country 115190 0
Australia
Phone 115190 0
+61 2 4620 3865
Fax 115190 0
Email 115190 0
j.zhou@westernsydney.edu.au
Contact person for public queries
Name 115191 0
Jerry Zhou
Address 115191 0
Dr Jerry Zhou
School of Medicine, Western Sydney University
Locked Bag 1797, Penrith South DC NSW 2751
Country 115191 0
Australia
Phone 115191 0
+61 2 4620 3865
Fax 115191 0
Email 115191 0
j.zhou@westernsydney.edu.au
Contact person for scientific queries
Name 115192 0
Jerry Zhou
Address 115192 0
Dr Jerry Zhou
School of Medicine, Western Sydney University
Locked Bag 1797, Penrith South DC NSW 2751
Country 115192 0
Australia
Phone 115192 0
+61 2 4620 3865
Fax 115192 0
Email 115192 0
j.zhou@westernsydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
In accordance with the data sharing guidelines in the approved ethics document, identifiable individual participant data (IPD) will not be available.

All participant data curated for statistical analysis will be anonymised before use.


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseRole of Baseline Gut Microbiota on Response to Fiber Intervention in Individuals with Irritable Bowel Syndrome.2023https://dx.doi.org/10.3390/nu15224786
N.B. These documents automatically identified may not have been verified by the study sponsor.