Trial Outcomes & Findings for Phase IV Study of the Impact of Dietary Fibers on Symptoms and Esophageal Motility in Patients With Non-erosive GERD (NCT NCT01882088)

NCT ID: NCT01882088

Last Updated: 2019-08-13

Results Overview

Number of gastroesophageal refluxes registered with 24-hours esophageal pH-impedance on the 10th day of psyllium intake. Statistical data represent the results of the comparison of the data obtained on the day 10 of study (EOT) with the baseline characteristics provided in the specific section

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

36 participants

Primary outcome timeframe

End of Treatment, on day 10 of psyllium intake

Results posted on

2019-08-13

Participant Flow

36 patients were enrolled. 1 patient withdrew informed consent before day 0, 1 excluded due to non-compliance, 1 could not tolerate oesophageal manometry, in 1 case there was no possibility to perform the manometry. Migration of the pH-impedance probe was found in two patients. The data of these mentioned 6 patients were excluded from the analysis

Participant milestones

Participant milestones
Measure	Mucofalk Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal Mucofalk: Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal
Overall Study STARTED	35
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Mucofalk Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal Mucofalk: Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal
Overall Study Intolerance of esophageal manometry	1
Overall Study no possibility to place the catheter	1
Overall Study Protocol Violation	1
Overall Study inadequate pH-impedance tracings	2

Baseline Characteristics

out of those who had hiatal hernia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mucofalk n=30 Participants Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal Mucofalk: Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal
Age, Continuous	34.7 years STANDARD_DEVIATION 9.3 • n=30 Participants
Sex: Female, Male Female	12 Participants n=30 Participants
Sex: Female, Male Male	18 Participants n=30 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=30 Participants
Race (NIH/OMB) Asian	0 Participants n=30 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=30 Participants
Race (NIH/OMB) Black or African American	0 Participants n=30 Participants
Race (NIH/OMB) White	30 Participants n=30 Participants
Race (NIH/OMB) More than one race	0 Participants n=30 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=30 Participants
Region of Enrollment Russia	30 participants n=30 Participants
body mass index, kg/m^2	36.7 kg/m^2 STANDARD_DEVIATION 6.9 • n=30 Participants
weight, kg	82.5 kg STANDARD_DEVIATION 17.9 • n=30 Participants
smoking status (yes)	6 Participants n=30 Participants
alcohol intake (yes)	14 Participants n=30 Participants
alcohol use (g/day)	1.1 g/day STANDARD_DEVIATION 1.7 • n=30 Participants
basal dietary fiber intake, g/day	6.0 g/day STANDARD_DEVIATION 2.3 • n=30 Participants
hiatal hernia presence	16 Participants n=30 Participants
hiatal hernia size	0.9 cm STANDARD_DEVIATION 0.5 • n=16 Participants • out of those who had hiatal hernia
stools per week, n	7.0 stools per week STANDARD_DEVIATION 2.0 • n=30 Participants
Number of Gastroesophageal Refluxes	67.9 refluxes a day STANDARD_DEVIATION 17.7 • n=30 Participants
Acid exposure time	5.6 Percent of time pH<4 per 24-hours period STANDARD_DEVIATION 4.8 • n=30 Participants
Number of acid gastroesophageal refluxes	43.2 acid refluxes per day STANDARD_DEVIATION 14.7 • n=30 Participants
Number of patients experiencing heartburn during 7 days prior to baseline	28 Participants n=30 Participants
minimal lower esophageal sphincter pressure at rest, mm Hg	22.0 mm Hg STANDARD_DEVIATION 9.4 • n=30 Participants
Mean resting lower esophageal sphincter (LES) pressure after 10 water swallows	20.5 mm Hg STANDARD_DEVIATION 9.5 • n=30 Participants
Minimal Resting Lower Esophageal Sphincter (LES) Pressure After 10 Water Swallows	14.1 mm Hg STANDARD_DEVIATION 8.0 • n=30 Participants
Residual Lower Esophageal Sphincter Pressure	7.5 mm Hg STANDARD_DEVIATION 6.1 • n=30 Participants
Mean Lower Esophageal Sphincter Pressure (at Rest)	22.0 mm Hg STANDARD_DEVIATION 9.4 • n=30 Participants

PRIMARY outcome

Timeframe: End of Treatment, on day 10 of psyllium intake

Population: Thirty-six patients were enrolled, complete data from 30 were included in the final analysis.

Outcome measures

Outcome measures
Measure	Mucofalk n=30 Participants Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal Mucofalk: Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal
Number of Gastroesophageal Refluxes	42.4 refluxes Standard Deviation 13.5

SECONDARY outcome

Timeframe: End of Treatment, on day 10 of psyllium intake

Population: Thirty-six patients were enrolled, complete data from 30 were included in the final analysis.

Percent of time with pH less than 4 at 5 cm above upper border of lower oesophageal sphincter per 24-hours oesophageal pH-impedance recording on the day 10 of psyllium intake. This outcome measure was compared to the baseline characteristics provided in the specific section of the study description

Outcome measures

Outcome measures
Measure	Mucofalk n=30 Participants Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal Mucofalk: Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal
Acid Exposure Time	5.5 Percent of time pH<4 per 24-hours period Standard Deviation 7.57

SECONDARY outcome

Timeframe: End of Treatment, on day 10 of psyllium intake

Population: 36 subjects were enrolled, data of 30 of them were included to the final analysis

Number of acid refluxes was measured by 24-hours oesophageal pH-impedance recordings. Reflux was considered as acid when oesophageal pH was less than 4 and the impedance revealed backward flow of the stomach content into the oesophagus. Outcome measure reflects the data of day 10 of psyllium intake. Statistics reflects comparison between EOT and baseline data.

Outcome measures

Outcome measures
Measure	Mucofalk n=30 Participants Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal Mucofalk: Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal
Number of Acid Gastroesophageal Refluxes	30.3 acid refluxes Standard Deviation 15.3

SECONDARY outcome

Timeframe: 7 days prior to EOT

Population: 36 patients were enrolled, data of 30 of them were included to the final analysis

Presence of heartburn during 7 days prior to the day 10 of psyllium intake was evaluated with a standardized questionnaire. This result was assessed at EOT

Outcome measures

Outcome measures
Measure	Mucofalk n=30 Participants Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal Mucofalk: Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal
Number of Patients Experiencing Heartburn During 7 Days Prior the Day 10 of Psyllium Intake	12 Number of participants

SECONDARY outcome

Timeframe: End of Treatment, on day 10 of psyllium intake

Population: 36 patients were enrolled. data of the 30 of them were available for the final analysis

Obtained during esophageal high resolution manometry study. End of treatment data were compared to the baseline. Per standard, resting pressure is measured during 30 seconds. High resolution manometry data on day 10 was compared to baseline.

Outcome measures

Outcome measures
Measure	Mucofalk n=30 Participants Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal Mucofalk: Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal
Minimal Lower Esophageal Sphincter Pressure at Rest	11.3 mm Hg Standard Deviation 9.4

SECONDARY outcome

Timeframe: End of Treatment, on day 10 of psyllium intake

Population: 36 patients enrolled, data of the 30 of them were available for the final analysis

The data are obtained during high resolution esophageal manometry study on the day 10 of psyllium intake. This outcome is measured after 10 water swallows by 5 ml each. The study usually lasts for about 15 to 20 minutes. Data of high-resolution esophageal manometry examination at baseline and on the day 10 of psyllium intake were compared.

Outcome measures

Outcome measures
Measure	Mucofalk n=30 Participants Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal Mucofalk: Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal
Mean Resting Lower Esophageal Sphincter (LES) Pressure After 10 Water Swallows at the End of Treatment (the Day 10 of Psyllium Intake)	22.0 mm Hg Standard Deviation 10.3

SECONDARY outcome

Timeframe: End of Treatment, on day 10 of psyllium intake

Population: 36 patients were enrolled, data of 30 of them were available for the final analysis

The results obtained during high resolution esophageal manometry studies. This parameter is obtained after 10 water swallows by 5 ml each. Data of high resolution esophageal manometry (examination usually lasts for 10-20 min) on the day 10 of psyllium intake were compared to the baseline characteristics. The data were compared to baseline characteristics

Outcome measures

Outcome measures
Measure	Mucofalk n=30 Participants Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal Mucofalk: Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal
Minimal Resting Lower Esophageal Sphincter (LES) Pressure After 10 Water Swallows	14.9 mm Hg Standard Deviation 6.4

SECONDARY outcome

Timeframe: End of Treatment, on day 10 of psyllium intake

Population: 36 non-erosive reflux disease (NERD) patients were enrolled, the data of 30 of them were available for the final analysis

These data are obtained during high resolution esophageal manometry studies. The end of treatment characteristics were compared to the baseline ones.

Outcome measures

Outcome measures
Measure	Mucofalk n=30 Participants Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal Mucofalk: Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal
Residual Lower Esophageal Sphincter Pressure	7.0 mm Hg Standard Deviation 5.4

OTHER_PRE_SPECIFIED outcome

Timeframe: End of Treatment, on day 10 of psyllium intake

Population: 36 subjects were enrolled, data of 30 of them were available for the final analysis

This parameter is obtained with the use of high-resolution esophageal manometry performed on the Day 10 of psyllium intake.

Outcome measures

Outcome measures
Measure	Mucofalk n=30 Participants Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal Mucofalk: Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal
Mean Lower Esophageal Sphincter Pressure (at Rest)	26.5 mm Hg Standard Deviation 11.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 7 days

Population: 36 patients were enrolled, complete data of 30 of them were available for the final analysis

Episodes of stools were calculated during 7-day period. Mean number at the end point was compared to the baseline one

Outcome measures

Outcome measures
Measure	Mucofalk n=30 Participants Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal Mucofalk: Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal
Stools Per Week	8.0 stools per week Standard Deviation 3.0

Adverse Events

Mucofalk

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Sergey Morozov, Senior Reseracher, Dpt Gastroenterology and Hepatology

Federal research Center of Nutrition and Biotechnology

Phone: +74996131091

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place