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D003248: Constipation

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

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Correlated Drug Terms (6)


Name (Synonyms) Correlation
drug2377 PDS-08 Wiki 1.00
drug1545 Hydroxychloroquine Sulfate 400 mg twice a day Wiki 1.00
drug1547 Hydroxychloroquine Sulfate 600 mg twice a day Wiki 1.00
Name (Synonyms) Correlation
drug1546 Hydroxychloroquine Sulfate 600 mg once a day Wiki 1.00
drug2557 Placebo oral tablet Wiki 0.18
drug2505 Placebo Wiki 0.05

Correlated MeSH Terms (1)


Name (Synonyms) Correlation
D012817 Signs and Symptoms, Digestive NIH 1.00

Correlated HPO Terms (0)


Name (Synonyms) Correlation

Clinical Trials

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There is one clinical trial.


1 A 12-week Randomized, Double-Blind Controlled Trial to Evaluate the Tolerability and Gastrointestinal Response of a Novel, Multi-Strain Synbiotic (PDS-08™) in Children Ages 3-17

Recent data support the use of specific probiotic strains in a pediatric population. However, given the wide number of commercial products available, and contradictory data in the literature, healthcare providers and consumers are uncertain about whether or not to use probiotics in children and which one(s) to choose. While much progress has been made in understanding the gastrointestinal microbiota and its role in the balanced development of the infant immune system, the tolerability and efficacy of introducing beneficial microbes into the pediatric gastrointestinal tract remain underexplored. The purpose of this study is to investigate the effect of a 9 strain synbiotic consortium comprised of strains with previous pediatric clinical data for use in modulating airway sensitivity, gastrointestinal discomfort, dermatological inflammation, and reduction in the duration and severity of upper respiratory tract infections in a pediatric population.

NCT04534036
Conditions
  1. Constipation
  2. Signs and Symptoms
  3. Digestive Signs and Symptoms
  4. Infrequent or Difficult Evacuation
Interventions
  1. Dietary Supplement: PDS-08
  2. Other: Placebo
MeSH:Constipation Signs and Symptoms, Digestive
HPO:Colonic inertia Constipation

Primary Outcomes

Description: Assessed as the change from Baseline for the continuous variable estimated using a repeated measures analysis of covariance (ANCOVA) model.

Measure: Change from baseline in weekly frequency of spontaneous bowel movements between groups.

Time: Baseline-Day 84

Secondary Outcomes

Description: Assessed by daily stool characteristics reported using the seven-point ordinal BSFS score. The BSFS classifies human stool into seven types and scores them accordingly. Type 1: Separate hard lumps (hard to pass) Type 2: Sausage-shaped and lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage, smooth and soft Type 5: Soft blobs with clear cut edges (passed easily) Type 6: Fluffy pieces with ragged edges, a mushy stool Type 7: Watery, no solid pieces, entirely liquid. Types 1 and 2 indicate constipation, with 3 through 4 represent the ideal stool form, and 5, 6, and 7 tend towards diarrhea. For a given assessment week, the weekly stool consistency is defined as the sum of non-missing stool consistency score for spontaneous bowel movements during that week divided by the number of non-missing stool consistency scores for spontaneous bowel movements during that week. The parameter will be analyzed using repeated measures ANCOVA model.

Measure: Change from baseline in Bristol Stool Form Scale (BSFS) score.

Time: Baseline-Day 84

Description: Assessed as the percentage of participants who are spontaneous bowel movement responders and have ≥4 per week and an increase of ≥1 bowel movement per week from baseline, including at least 3 weeks during weeks 9-12.

Measure: Overall spontaneous bowel movement response.

Time: Baseline-Day 84

Measure: Decrease in time from beginning to end of bowel movement of 10% or more from baseline.

Time: Baseline-Day 84

Description: Assessed by online daily symptom tracking of stool quality, regularity, ease of expulsion, bloating, flatulence, and intestinal transit time.

Measure: Changes in subjective assessment of gut tolerability and efficacy as reported by parents or direct relative guardians.

Time: Baseline-Day 84

Description: Microbiota composition will be identified through fecal samples for total genomic DNA extraction in participants supplemented with PDS-08 or placebo.

Measure: Change in microbiota composition at 3 months as assessed by whole genome shotgun sequencing.

Time: Baseline-Day 84

Measure: Change in fecal calprotectin, histamine, bacterial enzymes (β-glucosidase and β-glucuronidase), β-defensin (hBD2), and short-chain fatty acids (SCFAs) [Changes ≥ 25% relative to Baseline values].

Time: Baseline-Day 84

Measure: Improvement in QoL measured by the KINDL questionnaire [Changes ≥ 25% relative to Baseline score].

Time: Baseline-Day 84

Measure: Change in acne as measured by global count of blemishes [Changes ≥ 25% relative to Baseline score].

Time: Baseline-Day 84

Measure: Incidence of respiratory tract infections.

Time: Baseline-Day 84

HPO Nodes


HP:0002019: Constipation
Genes 382
SLC26A4 PPM1D ALAD NALCN VPS11 CAMTA1 SDHB KIT DNAJC13 SLC6A8 LIMK1 SOX3 KCNJ1 TTR SCN11A BIRC3 ELP1 NAB2 KCNAB2 CPOX GBA ADH1C CHST14 AFF4 NGLY1 PDGFRA PMS2 TCF4 EPCAM POLG ELN TRNF CTNS SIX3 PCCB TBP PHOX2B AVPR2 SYNJ1 ATRX RRM2B ATXN8OS UCHL1 MED25 BRCA1 RAI1 PROP1 PRDM16 KRT14 SCNN1B SMO KMT2A WASF1 SCN9A SNCA PROP1 TSHR CDKL5 NFIX SDHC MALT1 DHPS ND1 ND4 MLH3 MSH2 POLG2 NR4A2 HESX1 ALDOB RREB1 TRNE UBE3B ADNP LRIG2 PODXL WDR26 GIGYF2 POLG GRIN1 TRNQ EDN3 LHX3 TRNK RET P4HTM LRIG2 BCL10 RAI1 MRAP KCNH1 MDH2 COQ2 CAMK2B CHST14 SRCAP GATAD2B TBCD LRRK2 RERE NKX2-1 B2M NRXN1 PCCA FLI1 UBE3A MECP2 COL7A1 UFC1 MLXIPL COQ2 MITF EDN3 TGFBR2 CHD8 COX3 SALL1 PAX8 GDNF TRH UNC80 TNFRSF1A MLYCD MNX1 NALCN ARVCF VPS13C AQP2 ATRX SCN9A KDM1A NKX2-5 DSE UBE2A POLG IGHMBP2 DDHD2 SOX3 IQSEC2 SKI GBA RAI1 SEMA4A PARK7 HNRNPH2 POLG2 HTRA2 BAZ1B SCNN1A MED13 TRNS2 PROKR2 ASCL1 TAF1 WAC CISD2 VPS35 AQP2 EXT2 CDC73 MMP1 RAI1 SOX2 TXNRD2 SEMA3D OCRL ZSWIM6 CHCHD2 TLK2 DUOXA2 TRNS1 GP1BB TCF4 HNRNPK AVPR2 GTF2IRD1 PIK3CA UFD1 GDNF SLC12A3 SLC26A4 TRNH FAN1 DDC PAX8 FGF12 FLNA PCCB MAPT TSHR STAR DACT1 PINK1 MBD5 TWNK KIT RFC2 ATN1 SLC6A8 TRIO SOX10 SNCA PROP1 SCN10A POU1F1 TTR ADAT3 PCCA LHX4 HFE GTF2I SNCAIP TPO LRRK2 LMX1B EDNRB BMPR1A ATXN2 CACNA1S GJC2 FOXP1 EXT2 DPF2 OCRL EP300 HPSE2 TSHB VANGL1 MC2R FOXE1 DEAF1 DHCR7 UNC80 CLCNKB WDR26 CDC73 FGFR1 BRAF CLIP2 POGZ COMT HPSE2 HESX1 NRXN1 DDOST SLC5A5 CASR SH2B1 JMJD1C VPS11 TCF20 HESX1 PIGV SOX10 FOXP1 STAT6 PCGF2 DMPK DUOX2 HIRA PPOX APC SLC6A3 NNT MRPS34 STXBP1 FOXG1 GLI2 COX1 SPART THRA MSH6 SLC5A5 WFS1 PMS1 CREBBP TRNW OTUD6B COL7A1 PRNP TYMP EDN3 MMP1 ND5 UGP2 PAX8 FOXA2 TBX1 CHRM3 ATRX MLH1 PRKN FLII OTUD6B ZEB2 ND6 KRT5 TH PACS1 SLC12A3 PPOX IGH KRAS ARNT2 IYD ELN TG TRNL1 POGZ DDOST RET MED12 MEFV SMPD1 CNTNAP2 ECE1 SCN11A EDNRB KIT TRIO TBL2 OTX2 SDHB PACS1 HMBS SIK3 HMBS PAX8 CSNK2A1 LHX4 SEMA3C DES SETD5 ALPL LMNB1 TSHR SLC12A1 TBX1 GABRD RET TBCD DEAF1 MED12 RPS20 USP7 PEX16 COX2 PIGS NRTN ABL1 ATRX KCNJ18 SDHA ACTG2 CPOX OTX2 NKX2-5 CAVIN1 RET FTL SEC24C CAMTA1 TCF4 HIVEP2 MAGEL2 MECP2 EIF4G1 TRHR COL7A1 SLC6A3 SLC25A4 SPATA5 TRNL1 COL7A1 SCNN1G POU1F1 ARID2 SDHC CD96 GLUD2 DNAJC6 GABRA3
Protein Mutations 2
G1314A G1321A
SNP 0
Protein Mutations 0
SNP 0

HPO

Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


HPO Nodes


HP:0002019: Constipation
Genes 382
SLC26A4 PPM1D ALAD NALCN VPS11 CAMTA1 SDHB KIT DNAJC13 SLC6A8 LIMK1 SOX3 KCNJ1 TTR SCN11A BIRC3 ELP1 NAB2 KCNAB2 CPOX GBA ADH1C CHST14 AFF4 NGLY1 PDGFRA PMS2 TCF4 EPCAM POLG ELN TRNF CTNS SIX3 PCCB TBP PHOX2B AVPR2 SYNJ1 ATRX RRM2B ATXN8OS UCHL1 MED25 BRCA1 RAI1 PROP1 PRDM16 KRT14 SCNN1B SMO KMT2A WASF1 SCN9A SNCA PROP1 TSHR CDKL5 NFIX SDHC MALT1 DHPS ND1 ND4 MLH3 MSH2 POLG2 NR4A2 HESX1 ALDOB RREB1 TRNE UBE3B ADNP LRIG2 PODXL WDR26 GIGYF2 POLG GRIN1 TRNQ EDN3 LHX3 TRNK RET P4HTM LRIG2 BCL10 RAI1 MRAP KCNH1 MDH2 COQ2 CAMK2B CHST14 SRCAP GATAD2B TBCD LRRK2 RERE NKX2-1 B2M NRXN1 PCCA FLI1 UBE3A MECP2 COL7A1 UFC1 MLXIPL COQ2 MITF EDN3 TGFBR2 CHD8 COX3 SALL1 PAX8 GDNF TRH UNC80 TNFRSF1A MLYCD MNX1 NALCN ARVCF VPS13C AQP2 ATRX SCN9A KDM1A NKX2-5 DSE UBE2A POLG IGHMBP2 DDHD2 SOX3 IQSEC2 SKI GBA RAI1 SEMA4A PARK7 HNRNPH2 POLG2 HTRA2 BAZ1B SCNN1A MED13 TRNS2 PROKR2 ASCL1 TAF1 WAC CISD2 VPS35 AQP2 EXT2 CDC73 MMP1 RAI1 SOX2 TXNRD2 SEMA3D OCRL ZSWIM6 CHCHD2 TLK2 DUOXA2 TRNS1 GP1BB TCF4 HNRNPK AVPR2 GTF2IRD1 PIK3CA UFD1 GDNF SLC12A3 SLC26A4 TRNH FAN1 DDC PAX8 FGF12 FLNA PCCB MAPT TSHR STAR DACT1 PINK1 MBD5 TWNK KIT RFC2 ATN1 SLC6A8 TRIO SOX10 SNCA PROP1 SCN10A POU1F1 TTR ADAT3 PCCA LHX4 HFE GTF2I SNCAIP TPO LRRK2 LMX1B EDNRB BMPR1A ATXN2 CACNA1S GJC2 FOXP1 EXT2 DPF2 OCRL EP300 HPSE2 TSHB VANGL1 MC2R FOXE1 DEAF1 DHCR7 UNC80 CLCNKB WDR26 CDC73 FGFR1 BRAF CLIP2 POGZ COMT HPSE2 HESX1 NRXN1 DDOST SLC5A5 CASR SH2B1 JMJD1C VPS11 TCF20 HESX1 PIGV SOX10 FOXP1 STAT6 PCGF2 DMPK DUOX2 HIRA PPOX APC SLC6A3 NNT MRPS34 STXBP1 FOXG1 GLI2 COX1 SPART THRA MSH6 SLC5A5 WFS1 PMS1 CREBBP TRNW OTUD6B COL7A1 PRNP TYMP EDN3 MMP1 ND5 UGP2 PAX8 FOXA2 TBX1 CHRM3 ATRX MLH1 PRKN FLII OTUD6B ZEB2 ND6 KRT5 TH PACS1 SLC12A3 PPOX IGH KRAS ARNT2 IYD ELN TG TRNL1 POGZ DDOST RET MED12 MEFV SMPD1 CNTNAP2 ECE1 SCN11A EDNRB KIT TRIO TBL2 OTX2 SDHB PACS1 HMBS SIK3 HMBS PAX8 CSNK2A1 LHX4 SEMA3C DES SETD5 ALPL LMNB1 TSHR SLC12A1 TBX1 GABRD RET TBCD DEAF1 MED12 RPS20 USP7 PEX16 COX2 PIGS NRTN ABL1 ATRX KCNJ18 SDHA ACTG2 CPOX OTX2 NKX2-5 CAVIN1 RET FTL SEC24C CAMTA1 TCF4 HIVEP2 MAGEL2 MECP2 EIF4G1 TRHR COL7A1 SLC6A3 SLC25A4 SPATA5 TRNL1 COL7A1 SCNN1G POU1F1 ARID2 SDHC CD96 GLUD2 DNAJC6 GABRA3
Protein Mutations 2
G1314A G1321A
SNP 0
Protein Mutations 0
SNP 0

Reports

Data processed on September 26, 2020.

An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

Drug Reports   MeSH Reports   HPO Reports  

Interventions

4,180 reports on interventions/drugs

MeSH

691 reports on MeSH terms

HPO

263 reports on HPO terms

All Terms

Alphabetical index of all Terms

Google Colab

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