Open Label Tolerability Study of ISOThrive Prebiotic Nectar (MIMO) in Subjects With Constipation

NCT04677634 | Completed

• 1 other identifier: 1002
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose and efficacy endpoint of this study is to assess whether subjects with constipation predominant irritable bowel syndrome (IBS-C) or chronic Idiopathic constipation (CIC) tolerate ISOThrive.

Conditions

Constipation

Keywords

IBS-C; MIMO; remote

Outcome Measures

Primary Outcomes (3)

• Tolerability of ISOThrive using Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL)

  PAC-QOL a validated questionnaire which measures subject experience over the prior 2 weeks, includes a total of 28 items in 4 subscales: worries and concerns (11 items), physical discomfort (4 items), psychosocial discomfort (8 items), and satisfaction (5 items). Higher scores of PAC-QOL indicate more negative effects of constipation on the quality of life. This study will assess whether subjects with constipation tolerate ISOThrive by measuring the differences in baseline and post-intervention score using PAC-QOL. The score taken at the end of Week 1 of the Screening Phase will be compared to the scores at the end of Week 2 and Week 4 of the Tolerability Phase. Any difference in scores between Week 2 and Week 4 of the Tolerability Phase will also be compared. Tolerability is defined as the difference between the baseline score and the post-intervention score at Week 4 of the Tolerability Phase. It must be equal to or less than the baseline score.

  5 weeks

• Tolerability of ISOThrive using Patient Assessment of Constipation Symptoms (PAC-SYM)

  PAC-SYM is a validated 12 item constipation symptom questionnaire assessing symptoms over the prior 2 weeks. Sub-scores and total score vary from 0 to 4. All scores are given equal weight. A lower score indicates less symptom severity. This study will assess whether subjects with constipation tolerate ISOThrive by measuring the differences in baseline and post-intervention score using PAC-SYM. The score taken at the end of Week 1 of the Screening Phase will be compared to the scores at the end of Week 2 and Week 4 of the Tolerability Phase. Any difference in scores between Week 2 and Week 4 of the Tolerability Phase will also be compared. Tolerability is defined as the difference between the baseline score and the post-intervention score at Week 4 of the Tolerability Phase. It must be equal to or less than the baseline score.

  5 weeks

• Tolerability of ISOThrive using the Bristol Stool Scale (BSS)

  This study will assess whether subjects with constipation tolerate ISOThrive by measuring differences in pre and post-intervention scores using the BSS and bowel movement frequency. Electronic BSS diaries will be recorded daily. The BSS is an indicator of colonic transit time using a seven-point scale. Type 1 and 2 indicate hard stool; type 3, 4 and 5 show looser (ideal) stool; and type 6 and 7 indicate stool that is too loose. Tolerability is primarily defined as an increase in the frequency of bowel movements. Tolerability is secondarily defined as improvement in quality, a larger percentage of scores of 3, 4, and 5. Any difference in scores between weeks 1, 2, 3, and 4 of the Tolerability Phase will also be compared. Tolerability is defined as follows: average week 4 stool quality must be equal to or improved (equal to or more scores of 3, 4 and 5) relative to baseline, and average week 4 bowel movement frequency must be equal to or more than baseline frequency.

  5 weeks

Secondary Outcomes (1)

• Adverse Event Assessment

  5 weeks

Study Arms (1)

Tolerability Arm

OTHER

This is a single arm study. All subjects will receive the test material. The test material is ISOThrive. It is an approximately 90% pure maltosyl-isomalto-oligosacchride (MIMO) prebiotic syrup produced by bacterial fermentation/bio-conversion of sucrose and maltose. It is taken 1g daily for 30 days.

Dietary Supplement: ISOThrive Prebiotic Nectar

Interventions

ISOThrive Prebiotic Nectar DIETARY_SUPPLEMENT

The test material is ISOThrive. It is an approximately 90% pure maltosyl-isomalto-oligosacchride (MIMO) prebiotic syrup produced by bacterial fermentation/bio-conversion of sucrose and maltose. It is taken 1g daily.

Also known as: ISOT-101, maltosyl-isomaltooligosaccharides, MIMO

Tolerability Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English-speaking male and female adults between the ages of 18 and 75, inclusive
• Body mass index (BMI) \<35 and \>19, inclusive
• IBS-C or CIC based on the Rome IV criteria (see Appendix 1) determined via phone interview with the study coordinator and via responses to the questionnaire responses during the Screening Phase
• History (minimum of three months) of constipation as defined in appendix #1
• Must be on stable doses of medications, if any, prescribed for chronic conditions other than IBS-C or CIC
• If female of child-bearing age, must be on an active contraceptive measure or have male partner(s) with suitable protective measures
• Have access to a computer/tablet/phone with internet access and active e-mail account to complete electronic surveys daily throughout study participation
• Complete at least 5 of 7 daily BSS daily questionnaires and complete PAC-QOL and PAC-SYM questionnaires during the Screening Phase to enter the Tolerability Phase
• Complete 5 of 7 BSS daily questionnaires each week and PAC-QOL and PAC-SYM questionnaires at the end of weeks 2 and 4 of the Tolerability Phase to remain in the study
• Ability and willingness to give consent to participate in study

You may not qualify if:

• Significant comorbidities that are not medically stable
• History of any abdominal surgery involving the stomach, small or large intestine including appendectomy, cholecystectomy, pancreatic surgery, and any surgery involving abdominal trauma
• History of diabetes (type I or type II)
• History of any process that has resulted in abdominal adhesions, thus affecting gut motility
• History of defecatory or rectal evacuation disorders, which may be based on specific tests such as colonic transition time, manometry evaluation and defecography, such as pelvic floor dyssynergia or a reduction in intra-abdominal pressure (act of bearing down), rectal sensory perception, and rectal contraction (Ohkusa et al. 2019)
• History of diarrhea predominant or alternating diarrhea/constipation predominant IBS
• BMI \>=35, BMI \<=19
• Active history of nicotine use, cannabis use or alcohol abuse (as defined by: greater than 14 drinks/week or 4 drinks/day for men, 7 drinks/week or 3 drinks/day for women). Has used any tobacco, nicotine or cannabis products in the last 6 months or has abused alcohol in the last 6 months
• Taking any opioids or any other constipating medications within the prior month
• Must not take, and must not have taken within 3 weeks prior to commencing the Screening Phase, commercially available medications or supplements marketed as prebiotics or probiotics (Supplements such as Metamucil and Citrucel are acceptable in this study)
• Having taken a 10 day course of a single antibiotic within the past 3 months, \>10 day course of a single antibiotics during the past 5 months, or course of \>1 specific antibiotic within the past 5 months;
• Has any clinically significant finding which would confound the results, based on a physical exam or clinical laboratory testing after signing the consent but before receiving the first dose of study medication, based on determination by investigator;
• Reports using a prohibited medication or dietary supplement during the Screening Phase, or is not willing or able to abide by the restrictions regarding use of prohibited medications or dietary supplements;
• Reports using prokinetics, metformin, regular or frequent antibiotics, systemic glucocorticosteroids, regular non-steroidal anti-inflammatory drugs, sucralfate, ketoconazole, anticholinergics, or misoprostol. The regular intake of acetylsalicylic acid at doses up to 162 mg/day is permitted.
• Has used an antimicrobial mouth rinse within 1 month of enrollment (e.g. Listerene, etc.);

Sponsors & Collaborators

• ISOThrive Inc.: lead

Study Sites (1)

ISOThrive Inc.

Manassas, Virginia, 20109, United States

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• John Selling, MD

  ISOThrive Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 21, 2020
• Study Start: October 14, 2020
• Primary Completion: April 2, 2021
• Study Completion: April 2, 2021
• Last Updated: May 5, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)