Open Label Tolerability Study of ISOThrive Prebiotic Nectar, Maltosyl-Isomalto-oligosaccharides (MIMO), in Subjects With Constipation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Tolerability of ISOThrive using Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL)
研究概览
简要总结
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.
详细描述
Study Design 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.
Subjects will have been screened for CIC or IBS-C as determined by the Rome IV criteria during an interview with the study coordinator and by evaluation of the online questionnaire responses for PAC-QOL, PAC-SYM, and BSS. The study has been designed to have each subject serve as their own control so there will be no placebo arm. Each subject will receive ISOThrive according to the protocol. The goal is to assess 100 subjects after the Screening Phase. The study will be done remotely. There will be communication but no in person contact or visits with the study coordinator.
Two phases have been designed into this study. Phase 1 is the Screening Phase (SP) lasting 7 days. Phase 2 is the Tolerability Phase (TP) lasting 28 days. Subjects will be instructed to take a daily BSS questionnaire and bowel movement frequency throughout the study. They will note whether they have had bowel movements each day and describe them accordingly. At three timepoints, specific scores will be established for comparison and statistical analysis. These timepoints are: (1) SP7 - baseline without ISOThrive; (2) TP14 - 2 weeks using ISOThrive; (3) TP28 - 4 weeks using ISOThrive. At each of these timepoints, subjects will also complete the PAC-QOL and PAC-SYM validated questionnaires. Subjects will report any usage of laxatives and any changes in their usual medications throughout their study participation on a daily basis.
Enrollment An adequate number of individuals will need to be screened during the Screening Phase, using the disease specific validated questionnaires to yield approximately 100 qualified subjects to enter and likely complete the Tolerability Phase of the study. Individuals on medications for CIC or IBS-C may continue their medications during the trial as long as they are reported and do not deviate from the inclusion/exclusion criteria.
All subjects will be required to sign an IRB-approved informed e-consent that complies with the requirements of both 21 CRF Part 50 and Health Insurance Portability and Accountability Act (HIPAA) before entering the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.);
- •Having ever taken ISOThrive previously
- •History of recurrent infectious condition that requires intermittent antibiotic use
- •If female, is pregnant, lactating, or intending to become pregnant before, during or within 4 weeks after participating in this study or intending to donate ova during such time period
- •Primary sleep disorder including sleep apnea, restless leg syndrome, or insomnia
- •Colon prep or high colonic within 30 days prior to study entry
- •Use of any investigational product within 90 days prior to study entry
- •Participation in another investigation (clinical trial) during the course of this study
- •Participation in a rigorous weight loss program or have any planned changes in diet or lifestyle, such as getting married, change in residence, change in job, or other highly stressful event at any time during the study
- •Diagnosis of inflammatory bowel disease or chronic diarrhea, although a diagnosis of IBS-C or CIC with intermittent short-term diarrhea is acceptable
- •Employment (or relative of an employee) or involvement in any way with ISOThrive Inc.
- •An investigator, key study personnel or first degree relative of anyone involved with the study
- •Other conditions or situations that, in the investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
结局指标
主要结局
Tolerability of ISOThrive using Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL)
时间窗: 5 weeks
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.
Tolerability of ISOThrive using the Bristol Stool Scale (BSS)
时间窗: 5 weeks
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.
Tolerability of ISOThrive using Patient Assessment of Constipation Symptoms (PAC-SYM)
时间窗: 5 weeks
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.
次要结局
- Adverse Event Assessment(5 weeks)